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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
- 06948097063185 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
Category: Laryngeal mask airway, single-use
Laryngeal Mask Airways by Haiyan Kangyuan Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 920747b1-7b11-4d8f-bef9-5335e9732013 61 fields · synced Jun 18, 2026