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Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref PA0509Model without tubeRef PA1720Model with BagRef PA1723Ref PA0503Model with tubeRef PA0505Ref PA0500Ref PA0501Ref PA1714Ref PA1724Ref PA0504Ref PA0506Ref PA1713Ref PA1701Ref PA1704Ref PA1711Ref PA1703
Identity
- Trade Name
- Oxygen Mask EUDAMEDOxygen Mask with Reservoir Bag EUDAMED
- Device Name
- Oxygen Mask EUDAMEDOxygen Mask with Reservoir Bag EUDAMED
- Model / Reference
- without tube EUDAMEDPA0509 EUDAMEDwith Bag EUDAMEDPA1720 EUDAMEDPA1723 EUDAMEDwith tube EUDAMEDPA0503 EUDAMEDPA0505 EUDAMEDPA0500 EUDAMEDPA0501 EUDAMEDPA1714 EUDAMEDPA1724 EUDAMEDPA0504 EUDAMEDPA0506 EUDAMEDPA1713 EUDAMEDPA1701 EUDAMEDPA1704 EUDAMEDPA1711 EUDAMEDPA1703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310910743 EUDAMED06923310911849 EUDAMED06923310911870 EUDAMED06923310910668 EUDAMED06923310910699 EUDAMED06923310902755 EUDAMED06923310910675 EUDAMED06923310911832 EUDAMED06923310911887 EUDAMED06923310910705 EUDAMED06923310910736 EUDAMED06923310911825 EUDAMED06973073491843 EUDAMED06973073491874 EUDAMED06923310911801 EUDAMED06973073491867 EUDAMED
- Basic UDI-DI
- 69233109PA051EX EUDAMED69233109PA17M7 EUDAMED69233109PA05LY EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMEDR03010206 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 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 | 69233109PA051EX | 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 (16)
- EUDAMED 9605d27a-05ca-4a34-835b-4dc875b453c6 61 fields · synced Sep 18, 2026
- EUDAMED dc6bb985-9136-47c6-ae3c-e4af715c5f74 61 fields · synced May 16, 2026
- EUDAMED a14ae7bf-c9e3-408a-b795-7360d6a26ef5 61 fields · synced May 16, 2026
- EUDAMED f7fdc6ea-b3c1-4b7e-8476-8dd48d5fb6c7 61 fields · synced May 16, 2026
- EUDAMED c9241bf8-2310-4cff-8f27-753ed728bf11 61 fields · synced May 17, 2026
- EUDAMED 4d13c18c-7b15-4ab4-a075-196e6c575919 61 fields · synced May 17, 2026
- EUDAMED 8c108734-1936-4212-bd63-a83af665bff8 61 fields · synced May 17, 2026
- EUDAMED 37d604ed-4a14-4438-9f09-569b8cb15b99 61 fields · synced May 18, 2026
- EUDAMED 554e5c0c-e8b7-4834-9351-3bb72efae8a0 61 fields · synced May 18, 2026
- EUDAMED ae142e1e-191e-4888-8c08-68042969666b 61 fields · synced May 18, 2026
- EUDAMED df9a2e7c-32ee-427c-9fb8-e43fb9e76a30 61 fields · synced May 18, 2026
- EUDAMED 7617352b-7467-4d43-9689-6dae3580698f 61 fields · synced May 18, 2026
- EUDAMED a3d48067-0a3f-431d-b8e5-b7ec77274292 61 fields · synced May 18, 2026
- EUDAMED a7f31c9e-f2b0-49d6-87b1-943da334e01d 61 fields · synced May 18, 2026
- EUDAMED 4a2b854a-d36b-4a51-97c9-e9deae224acb 61 fields · synced May 18, 2026
- EUDAMED 21ea4c62-a703-4212-aacd-53d0cb6a586c 61 fields · synced May 19, 2026