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Face Mask
EUDAMEDClass I (EU MDR)
Ref Type IIRModel 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 IIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502824711 EUDAMED06978502824667 EUDAMED06978502824698 EUDAMED06978502824650 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 — CE/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 (4)
- EUDAMED 067553e2-bff8-4659-9136-3fd050bbb88e 61 fields · synced Oct 7, 2026
- EUDAMED edf059f5-2dd8-4216-a509-3065129d2334 61 fields · synced May 17, 2026
- EUDAMED aaa250e1-f538-4dfd-85e2-aff739f9a263 61 fields · synced May 19, 2026
- EUDAMED 76170911-e9c5-464c-88ca-a8112a321d9c 61 fields · synced May 19, 2026