Identity
- Trade Name
- Aerosol Mask EUDAMED
- Device Name
- NEBULIZER MASK EUDAMED
- Model / Reference
- YM-A004 EUDAMEDMTN-XL-BF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580754643 EUDAMED
- Basic UDI-DI
- 697458075A0042F5V EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS 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
Aerosol Mask 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 | 697458075A0042F5V | 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 0b741bf0-6e10-42ed-8600-0d58bbf07b46 61 fields · synced Jul 9, 2026