Identity
- Device Name
- Face Masks EUDAMED
- Model / Reference
- EFSERIES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712832469790 EUDAMED
- Basic UDI-DI
- 471283246FMT2 EUDAMED
- Direct Marketing DI
- 04712832469790 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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 Masks by Aero Pro 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 | 471283246FMT2 | Class I | Active |
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Manufacturer
- Manufacturer
- Aero Pro Co., Ltd.
- EUDAMED SRN
- TW-MF-000012343
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED a15a7d84-e269-4ae9-b2dc-ddbb190027cf 61 fields · synced Jun 18, 2026