Identity
- Trade Name
- Surgical Face Mask EUDAMED
- Device Name
- Surgical Face Mask EUDAMED
- Model / Reference
- FM-III-I EUDAMEDJHFM004-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948788160131 EUDAMED
- Basic UDI-DI
- 694878811006PY EUDAMED
- Secondary DI
- 04251873710015 EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Face Mask by Hubei Qianjiang Kingphar Medical 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 | 694878811006PY | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Qianjiang Kingphar Medical Material Co., Ltd
- EUDAMED SRN
- CN-MF-000009051
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9d9df22a-f596-4f71-ba04-792e99a186ce 61 fields · synced Jun 18, 2026