Certifications & Compliance
Where a document has a public register, the number is printed on this page so you can look it up without asking us. Where it does not — a Declaration of Conformity has no public register — we tell you how to check it instead of hiding behind a badge.
We also list what is not in the folder, and which requirements do not apply to this device class at all, because that is the part buyers normally discover after the deposit.
How to verify a Chinese supplier in four steps
The same checklist we expect our own buyers to run on us. Twenty minutes, and it filters out most of the documentation problems you would otherwise find after payment.
Ask for the document, not the logo
A certificate claim is only worth the PDF behind it. If a supplier sends an image with the number cropped out, treat it as unverified — that is usually deliberate.
Check the number with the issuer
Use the certification body’s own register, not the certificate itself and not the supplier’s website. The number should return an active status and a scope covering the products you are buying.
Read what the document actually covers
This is where most buyers get caught. A GPSR certificate, a RoHS report and an MDR declaration are all “CE” documents, and only one of them is a medical device assessment. Check the standard numbers, not the badge.
Match the legal entity name
The name on the certificate, the business licence and the invoice must be the same legal entity. Mismatches here are the most common problem in Chinese documentation packages.
Quality management system
How the factory is run.
ISO 13485:2016 — Medical device quality management system
Huarenlian Certification Service Co., Ltd. (华认联)
Issued 2025-06-19 · valid to 2028-06-18
Standard / basis
GB/T 42061-2022 / ISO 13485:2016
Covers
Guangdong Jinda health care Co., Ltd — sales and production of Class I medical devices, including walking aids, bath safety seating, commode chairs and toilet safety rails.
What it is
The quality system certificate most EU and Middle East importers require before a first order. It speaks to how the factory is run, not just to how one sample tested.
What it is not
It is not a product certificate. It does not certify any individual model, and it does not replace a Declaration of Conformity.
How to check it yourself
Check the number and the scope wording against the certification body’s register, and confirm the legal entity on the certificate matches the business licence. Ask for the PDF and the licence side by side.
ISO 9001:2015 — Quality management system
Huarenlian Certification Service Co., Ltd. (华认联)
Issued 2025-06-19 · valid to 2028-06-18
Standard / basis
GB/T 19001-2016 / ISO 9001:2015
Covers
General manufacturing quality management across the Zhongshan facility, including Class I medical device production and sales.
What it is
Useful for tender documents, and for buyers whose customer asks for ISO 9001 specifically rather than ISO 13485.
What it is not
ISO 9001 alone does not satisfy medical device import requirements — if a distributor asks for 13485, this certificate will not substitute for it.
How to check it yourself
Same method as the 13485 certificate: number against the issuer’s register, and read the scope line, not the logo.
Regulatory declarations
The documents that make CE marking and US import lawful — issued by us, checked by you.
EU MDR Declaration of Conformity — CE marking under 2017/745
Held — copy on requestGuangdong Jinda health care Co., Ltd — manufacturer’s own declaration
Issued per model and per production run
Standard / basis
Regulation (EU) 2017/745 (MDR), Annex IV content · risk management to EN ISO 14971 · information supplied by the manufacturer to EN ISO 1041
Covers
Class I rehabilitation equipment placed on the EU market under our own name — walking aids, bath safety seating, commode chairs, walkers and toilet safety rails. The declaration names the models it covers; a model not named on it is not covered by it.
What it is
The document that actually makes CE marking lawful for a medical device. It states the device class, the models covered, the standards applied and the person signing on behalf of the manufacturer. For Class I devices the manufacturer declares conformity itself — there is no notified body certificate behind it, and none is required.
What it is not
It is not a notified-body certificate, and it is not the GPSR certificate listed above. If your distributor or tender treats the product as a higher class — for example an electrically powered or body-invasive variant — the route is different and we will say so before you order.
How to check it yourself
There is no public register for a Declaration of Conformity — that is exactly why it is the easiest document to fake. Check it three ways: the legal entity and address match the ISO 13485 certificate, the model you are buying is named on it, and the standards listed match what your market requires. Then ask the signatory to confirm the version date in writing.
US FDA establishment registration & device listing
Held — copy on requestUS Food and Drug Administration — registrant: Guangdong Jinda health care Co., Ltd
Registration is renewed annually, 1 October – 31 December
Standard / basis
FD&C Act · 21 CFR Part 807 (establishment registration and device listing)
Covers
The Zhongshan manufacturing facility and the Class I rehabilitation products listed for export to the United States. Device listing is per product, so confirm the listing covers the specific model and product code you are importing.
What it is
Registration and listing are what US customs brokers and marketplace compliance teams actually look up: the facility appears in the FDA establishment database, and each device appears in the listing database under its product code. For the product codes covering walking aids, bath chairs, commode chairs and walkers, premarket notification under 510(k) is generally not required — which is why these reach the US as Class I listed devices.
What it is not
Registration is not approval, and FDA does not “approve” Class I devices. If any supplier of this product category tells you they are “FDA approved”, the term is being misused — the correct wording is registered and listed. Registration also does not certify that a given unit meets the specification.
How to check it yourself
Search both FDA public databases yourself: the establishment registration database for the facility name and address, then the device listing database for the product code. Ask us for the registration number and the listing numbers, and match them against what the databases return — the numbers should resolve to the Zhongshan address, not to a trading company.
Open the public register →Product conformity & testing
What was tested, on which model, to which standard.
EU GPSR Certificate of Compliance — CE marking
Shenzhen Tianqi Testing Technology Service Co., Ltd. (TQT)
Issued 2026-06-10
Standard / basis
EN 12520:2024 · EN 1728:2012 · EU GPSR 2023/988
Covers
Folding shower stool, main test model LM5108 (test report TQT1520D368E). The certificate states that it applies to the tested sample and does not assess the whole production.
What it is
A product-safety conformity certificate issued under the EU General Product Safety Regulation, tested to the European seating strength and durability standards EN 12520 and EN 1728. It permits CE marking to demonstrate compliance with GPSR.
What it is not
It is not a medical device conformity assessment under MDR 2017/745. EN 12520 and EN 1728 are furniture seating standards, not medical device standards.
How to check it yourself
Ask for the certificate together with test report TQT1520D368E, then confirm the model number and the standards on the certificate match the product you are buying. The report is the evidence; the certificate is the summary.
EU RoHS test report — bath chair series
South China Technical Service Co., Ltd. (GD-SCT)
Issued 2025-04-01
Standard / basis
RoHS Directive 2011/65/EU & (EU) 2015/863
Covers
Bath chair, test model LM3200, covering series LM5101, LM5103, LM5104, LM3201, LM3202, LM3203, LM3004, LM3205, LM3206. Result: pass.
What it is
Evidence that restricted substances (lead, cadmium, mercury, hexavalent chromium, PBBs, PBDEs) are within RoHS limits on the tested models.
What it is not
RoHS is a hazardous-substance directive, not a medical device or general product safety assessment. It is not the document a distributor means when they ask for “CE”.
How to check it yourself
Request the full report, check the model and series list against your order, and read the conclusion line of each test item.
EU RoHS test report — commode chair series
South China Technical Service Co., Ltd. (GD-SCT)
Issued 2025-04-01
Standard / basis
RoHS Directive 2011/65/EU & (EU) 2015/863
Covers
Commode chair, test model LM6207, covering series LM6201–LM6209 and LM252. Result: pass.
What it is
The same substance-limit evidence as the bath chair report, applied to the commode chair series.
What it is not
Not a mechanical strength or medical device conformity document.
How to check it yourself
Same method as above: match the model and series list, and read the conclusion per test item.
Intellectual property
What is protected, and where.
EUIPO registered Community design — carbon fibre cane
European Union Intellectual Property Office (EUIPO)
Issued 2026-02-27
Standard / basis
Registered Community design · Locarno class 03-0351 (canes)
Covers
The external appearance of the carbon fibre walking cane, registered to Guangdong Jinda health care Co., Ltd, with the designer named on the register.
What it is
A registered design protects the look of the product in the EU. It matters to buyers investing in artwork, tooling or a private label range built on that shape.
What it is not
It is a design registration, not a patent — it protects appearance, not a technical mechanism or a material formula.
How to check it yourself
Search the design number in the EUIPO eSearch plus database. Registrations are public and show the holder, the designer and the renewal dates.
Open the public register →What we do not hold — and what does not apply
Being specific about the gaps is the fastest way for you to work out whether we are the right supplier for your market. Some of these are genuinely missing; one of them is a requirement that cannot exist for this device class, and we would rather explain why than send you a document for a different product.
| Notified body certificate under MDR Does not apply to Class I | Class I devices are self-declared, so there is no notified body certificate to show — for us or for any competitor selling the same class. If your tender template demands one, the requirement does not match the device class, and we will say that rather than send you a certificate for a different product. |
| Mechanical strength test to a medical device standard Not in this folder | The strength evidence on file is EN 12520 / EN 1728, which are furniture seating standards. If your tender or distributor specifies a medical device standard such as ISO 7176 or a national variant, that test has to be commissioned separately — we will quote the lead time rather than imply the existing report covers it. |
| Social compliance audit (BSCI / Sedex) On request | We host buyer and third-party audits. Tell us which scheme your customer requires and we will confirm what is currently on file before you commission a new one. |
| EU REACH SVHC declaration for every component Per model — quote stage | RoHS reports cover the electrical and metal content of the tested series. REACH SVHC is a separate declaration and is issued per model against the current candidate list. Ask for it with the model numbers and we will confirm which version applies. |
Documents that ship with every order
Not “available on request after payment” — these reach you before the vessel sails.
- Declaration of Conformity — Issued for the exact model and batch shipped, not a generic template.
- Batch inspection report — Load test, visual inspection and packing check for the production batch.
- Test reports covering that model — The report numbers listed on this page, where they cover the model you ordered.
- Packing list & commercial invoice — Carton dimensions, gross/net weight and HS code for customs.
- Labelling artwork for your market — Including the importer block, in the language your market requires.
Questions buyers ask about this page
Is your CE marking a medical device certificate?
Can you send the certificate PDFs before we place an order?
The ISO 13485 certificate is issued by a Chinese certification body. Does that matter?
Do you have FDA registration?
What ships with each order?
Want the document package for your market?
Tell us the destination country and the model. We send the certificate copies, the declaration of conformity and the label version your customs broker will ask for — and we tell you which document does not cover that model, if any.