Identity
- Trade Name
- SIMPLE OXYGEN MASK EUDAMED
- Device Name
- OXYGEN MASK EUDAMED
- Model / Reference
- GT010-110-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958627548631 EUDAMED
- Basic UDI-DI
- B-06958627548631 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Simple Oxygen Mask by Ningbo Greetmed Medical 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-06958627548631 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Greetmed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009634
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7f6dd792-3869-48b6-8057-f1472020153f 61 fields · synced Aug 4, 2026