Identity
- Trade Name
- AIR CUSHION FACE MASKS EUDAMEDAIR CUSHION FACE MASK EUDAMED
- Device Name
- AIR CUSHION FACE MASKS EUDAMEDAIR CUSHION FACE MASK EUDAMED
- Model / Reference
- YM-A010 EUDAMEDMAP-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974580754940 EUDAMED
- Basic UDI-DI
- 697458075A010FB8 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Category: Anaesthesia face mask, single-use
Air Cushion Face Masks by Ningbo Yingmed Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 697458075A010FB8 | 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 (2)
- EUDAMED 05d1d90f-ba4d-4658-9998-a361858293d3 61 fields · synced Aug 1, 2026
- EUDAMED 6ad9bb3a-2130-415a-b0da-092c1ac1dffe 61 fields · synced Aug 1, 2026