Identity
- Trade Name
- oxygen mask EUDAMED
- Device Name
- oxygen masks EUDAMED
- Model / Reference
- 20838 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970879338822 EUDAMED
- Basic UDI-DI
- B-06970879338822 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
oxygen mask by Ningbo Pinmed Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970879338822 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Pinmed Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000008488
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 217549ad-9187-4d93-810b-795743defd1f 61 fields · synced Jul 9, 2026