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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
- 06978502824636 EUDAMED06978502824612 EUDAMED06978502824599 EUDAMED06978502824643 EUDAMED06978502824629 EUDAMED06975652001955 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 EUDAMEDDenmark 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 (6)
- EUDAMED 4670c3d0-f52b-4b40-a4fb-be332f39b2c6 61 fields · synced Oct 8, 2026
- EUDAMED 19e04074-be71-4198-886e-e07b55d5f265 61 fields · synced May 17, 2026
- EUDAMED bb66e164-8be9-47a9-8262-f59810ad267e 61 fields · synced May 19, 2026
- EUDAMED aca73051-c23a-41eb-8b46-abab30268bdb 61 fields · synced May 19, 2026
- EUDAMED 1afbc2c9-9470-40b0-a969-cf241db6a5e8 61 fields · synced May 19, 2026
- EUDAMED af24ea03-862f-4b09-be37-602ca26c7666 61 fields · synced May 19, 2026