Identity
- Device Name
- nasal strips EUDAMED
- Model / Reference
- HLK04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979080920017 EUDAMED
- Basic UDI-DI
- 697908092datzzy04MB EUDAMED
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nasal strips by Quanzhou Honglinkai New Material Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697908092datzzy04MB | Class I | Active |
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Manufacturer
- Manufacturer
- Quanzhou Honglinkai New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000049679
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED b203a67b-8f40-4f1d-b0e0-22716004d791 61 fields · synced Jul 8, 2026