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oxygen masks with reservoir bag
EUDAMEDClass IIa (EU MDR)
Ref GT010-160Model XLModel M
Identity
- Trade Name
- oxygen masks with reservoir bag EUDAMED
- Device Name
- oxygen masks with reservoir bag EUDAMED
- Model / Reference
- XL EUDAMEDGT010-160 EUDAMEDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970879339416 EUDAMED06970879339423 EUDAMED
- Basic UDI-DI
- B-06970879339416 EUDAMEDB-06970879339423 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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 masks with reservoir bag 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-06970879339416 | 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 (2)
- EUDAMED e319dd80-b7fe-4ba4-94d7-b94cb9f1a6f9 61 fields · synced Jul 22, 2026
- EUDAMED ad5fd8d4-4856-446b-be52-9f25a798e127 61 fields · synced May 19, 2026