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Laryngeal Mask Airways
EUDAMEDClass IIa (EU MDR)
Ref /Model standard type, reinforced type, double lumen standard type, double lumen reinforced type
Identity
- Device Name
- Laryngeal Mask Airways EUDAMED
- Model / Reference
- standard type, reinforced type, double lumen standard type, double lumen reinforced type EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948097063192 EUDAMED
- Basic UDI-DI
- 6948097011HZQ4 EUDAMED
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Laryngeal Mask Airways by Haiyan Kangyuan Medical Instrument 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 | 6948097011HZQ4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Haiyan Kangyuan Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001532
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 18eead04-9433-4ba6-adc1-387ba50e9b79 61 fields · synced Oct 5, 2026