Identity
- Device Name
- Respirators EUDAMED
- Model / Reference
- AP22103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712832461558 EUDAMED
- Basic UDI-DI
- 471283246DRTFDA EUDAMED
- Direct Marketing DI
- 04712832461558 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - 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
Category: Anaesthesia face mask, single-use
Respirators by Aero Pro Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471283246DRTFDA | 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 c02b2d85-efc7-4401-91a0-2764f0d7bc11 61 fields · synced Jun 18, 2026