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Silicone Laryngeal Mask Airway
EUDAMEDClass IIa (EU MDR)
Ref EC160240PRModel Reinforced4
Identity
- Trade Name
- Silicone Laryngeal Mask Airway EUDAMED
- Device Name
- Silicone Laryngeal Mask Airway EUDAMED
- Model / Reference
- Reinforced4 EUDAMEDEC160240PR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951012114 EUDAMED
- Basic UDI-DI
- B-06941951012114 EUDAMED
- EMDN Code
- R010280 LARYNGEAL MASKS AND TUBES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Laryngeal Mask Airway by Guangdong Ecan Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941951012114 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED e61006ab-a349-4e69-a081-b1b67fac1e0c 61 fields · synced Jun 18, 2026