Identity
- Trade Name
- CPAP Replacement Headgear EUDAMED
- Device Name
- CPAP Replacement Headgear EUDAMED
- Model / Reference
- YM-ML1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906118133536 EUDAMED
- Basic UDI-DI
- 890611813YM-ML10017F 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 Headgear 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-ML10017F | 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 7b0c2be0-a139-4095-9446-a313a9f37412 61 fields · synced Jun 18, 2026