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 consumables (nasal strips and body patches). 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: Class I medical consumables (nasal strips, body patches) for export
- Issued: 5 August 2025
- 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. For full Class I medical-device manufacturing, HLK also maintains an ISO 13485 chain through its processing partner (manufacturing-chain ISO 13485, not a personal HLK certificate). 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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