Identity
- Trade Name
- simple mask EUDAMED
- Device Name
- Simple Mask EUDAMED
- Model / Reference
- SM08 EUDAMEDAS-SM-279 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974448152796 EUDAMED
- Basic UDI-DI
- 697444815SM08PJ EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES 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
simple mask by Anji Anshen Surgical Dressings 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 | 697444815SM08PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Anji Anshen Surgical Dressings Co., Ltd.
- EUDAMED SRN
- CN-MF-000013693
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED ac4be5a1-a57e-4d03-868d-b9bd4702a6c9 61 fields · synced Oct 6, 2026