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Face Mask
EUDAMEDClass I (EU MDR)
Ref Type IIModel Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3
Identity
- Trade Name
- FACE MASK EUDAMED
- Device Name
- FACE MASK EUDAMED
- Model / Reference
- Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3 EUDAMEDType II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502824605 EUDAMED
- Basic UDI-DI
- 697565200FM001CT EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Face Mask by Hubei Guarddent Medical Technology 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 | 697565200FM001CT | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 37009b70-9c84-4a2d-8642-b5ab6a697cd1 61 fields · synced Jun 19, 2026