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Laryngeal Mask Airway
EUDAMEDClass IIa (EU MDR)
Ref LMAN415Model Non-inflatable
Identity
- Device Name
- Laryngeal Mask Airway EUDAMED
- Model / Reference
- Non-inflatable EUDAMEDLMAN415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16938119395780 EUDAMED
- Basic UDI-DI
- 693811938771KU EUDAMED
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 Airway by Henan Tuoren Medical Device 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 | 693811938771KU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henan Tuoren Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000013924
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (1)
- EUDAMED 6eff5d2f-1c00-4f8e-a861-18e0dc306f22 61 fields · synced Jun 14, 2026