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Oxygen Mask with Reservoir Bag
EUDAMEDClass IIa (EU MDR)
Ref PA1710Model with Bag
Identity
- Trade Name
- Oxygen Mask with Reservoir Bag EUDAMED
- Device Name
- Oxygen Mask with Reservoir Bag EUDAMED
- Model / Reference
- with Bag EUDAMEDPA1710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310911795 EUDAMED
- Basic UDI-DI
- 69233109PA17M7 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa 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
Oxygen Mask with Reservoir Bag by Hangzhou Formed Medical Devices Co., Ltd. — Class IIa — 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 | 69233109PA17M7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 22c9a64c-ec5e-4fe9-a28f-c0d52fa19564 61 fields · synced Jun 19, 2026