Identity
- Device Name
- Oxygen Masks EUDAMED
- Model / Reference
- XL, L, M, S, XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970413330022 EUDAMED
- Basic UDI-DI
- 697041333YT002001JP EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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 Masks by Zhejiang Yuantong Medical Appliances 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 | 697041333YT002001JP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Yuantong Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000020693
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED e217b9b8-1a90-4b94-a86f-f6401c9758b5 61 fields · synced Oct 6, 2026
- EUDAMED e217b9b8-1a90-4b94-a86f-f6401c9758b5-1 61 fields · synced Jun 10, 2026