Identity
- Trade Name
- CPAP Replacement Mask Cushion EUDAMED
- Device Name
- CPAP Replacement Mask Cushion EUDAMED
- Model / Reference
- YM-ML1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906118133482 EUDAMED
- Basic UDI-DI
- 890611813YM-ML10027H EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
CPAP Replacement Mask Cushion by Techo Info Ltd — Class I — 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 | 890611813YM-ML10027H | Class I | Active |
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Manufacturer
- Manufacturer
- Techo Info Ltd
- EUDAMED SRN
- UK-MF-000048031
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 1cef62e8-5762-4716-b488-b6e4da9e6060 61 fields · synced Sep 18, 2026