Importing a new class I medical device from a new manufacturer always starts with the same question: “Are they real?” Public records are the only answer a buyer doesn’t have to take on trust. Quanzhou Honglinkai New Material Co., Ltd. (“HLK”) is verifiable in three independent public registries — and the EU one is new.
1. EU EUDAMED — Manufacturer record (added 24 September 2025)
On 24 September 2025, HLK was added to the European Database on Medical Devices (EUDAMED) as a Manufacturer of medical devices. EUDAMED is the public registry established under EU MDR 2017/745; importers, distributors, notified bodies and EU customs use it to confirm a manufacturer’s identity.
- SRN (Single Registration Number): CN-MF-000049679
- Role: Manufacturer
- Country: China
- Legal entity: Quanzhou Honglinkai New Material Co., Ltd.
- National trade register ID: 91350502MA8U7RXC95
You can look up the record directly: ec.europa.eu/tools/eudamed/…/08c5e2da-2b2e-4eda-9b65-db4b4c917939
The SRN is the number an EU importer cites in its own EUDAMED registration, customs declarations and post-market surveillance reports. The earlier HLK has its SRN, the earlier an EU private-label buyer can finish the MDR paperwork on its own side.
2. China ISO 9001:2015 — Quality management system (current)
HLK holds a current GB/T 19001-2016 / ISO 9001:2015 quality-management-system certificate covering the export of Class I medical devices (nasal strips, mouth tape and body tape). The certificate is filed in the public CNCA (国家认证认可信息公共服务平台) registry, the official accreditation information platform of the State Administration for Market Regulation.
- Standard: GB/T 19001-2016 / ISO 9001:2015
- Scope: Export of Class I medical devices (nasal strips, mouth tape, body tape)
- Issued: 6 August 2026
- Valid until: 5 August 2029
- Accreditation mark: IAS
- Headcount covered: 15
You can search the record yourself at cx.cnca.cn — the public CNCA certification information platform.
ISO 9001 is the baseline quality-management standard. HLK also holds ISO 13485:2016 in its own name — certificate RZ7530335, valid 29 May 2026 to 28 May 2029 — with a scope covering the sale of Class I semi-finished devices. We would rather name that scope than imply a wider one. The full portfolio — REACH SVHC, RoHS 2.0, PFAS-free, MSDS, ISO 10993 skin-irritation testing — is summarised on the Trust & Compliance page.
3. China Customs — Import / export credit (general credit enterprise)
On the China Customs credit-publicity platform (中国海关企业进出口信用信息公示平台), HLK is registered as a general credit enterprise (常规企业) for the import and export of other chemical products, with annual reporting filed on time.
- Registered entity: 泉州市宏霖楷新材料有限公司 (Quanzhou Honglinkai New Material Co., Ltd.)
- Unified social credit code: 91350502MA8U7RXC95
- Customs office: 泉州刺桐办 (Quanzhou Citong office)
- Industry classification: Other chemical products wholesale
- Annual filing status: 已报送 (filed)
For an EU importer this is the routine proof that the factory can clear Chinese export customs in its own name — no shadow trading company inserted in the middle, no re-routed paperwork.
How to verify HLK yourself
| Registry | Look up at | What it confirms |
|---|---|---|
| EU EUDAMED | ec.europa.eu/tools/eudamed | EU MDR manufacturer registration (SRN) |
| China CNCA (国家认监委) | cx.cnca.cn | ISO 9001:2015 QMS certificate status |
| China Customs | credit.customs.gov.cn | Import / export credit record |
All three are government-run public registries. The same record HLK shows to an importer in Frankfurt is the one you’d see in Düsseldorf, Madrid or Hamburg.
What is not on this list
- ISO 13485: held through HLK’s manufacturing partner, not as a personal HLK certificate. The processing chain is documented and disclosed to OEM buyers.
- EU DoC (Declaration of Conformity): issued per SKU and shipped with every carton. For product-level DoC requests, see the OEM page or email sales.
- CE marking on the retail carton: applies to medical devices that go through a notified body. HLK’s Class I nasal strips and mouth tape are self-declared under MDR Article 19 and carry a DoC; no notified-body step is required for these categories.
Want the full compliance pack?
For a serious OEM enquiry, request the compliance pack directly — DoC, ISO 13485 statement, REACH SVHC letter, RoHS 2.0, PFAS-free test, MSDS, and batch-level CoC. Sent the same business day; no NDA required for general documentation.
HLK — Quanzhou Honglinkai New Material Co., Ltd. — EUDAMED SRN CN-MF-000049679 | ISO 9001:2015 | China Customs general credit | OEM/ODM for nasal strips, mouth tape and body patches since 2005.
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