Identity
- Trade Name
- NON-REBREATHING MASKS EUDAMED
- Device Name
- Oxygen Mask With Tubing Reservoir Bag S EUDAMED
- Model / Reference
- YM-A006 EUDAMEDMTW-M-BF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580754667 EUDAMED
- Basic UDI-DI
- 697458075A006PC9 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Non-Rebreathing Masks by Ningbo Yingmed Medical Instruments 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 | 697458075A006PC9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Yingmed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000002183
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fe029bf5-a3d9-4207-8bdb-ca434d7629e7 61 fields · synced Jul 10, 2026