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Silicone Laryngeal Mask Airway
EUDAMEDClass IIa (EU MDR)
Ref R010280Model Reinforced2½
Identity
- Trade Name
- Silicone Laryngeal Mask Airway EUDAMED
- Device Name
- Silicone Laryngeal Mask Airway EUDAMED
- Model / Reference
- Reinforced2½ EUDAMEDR010280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951012091 EUDAMED
- Basic UDI-DI
- B-06941951012091 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 — CE/MDR — 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-06941951012091 | 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 daf86c36-1de8-48e2-bf7b-b42412e63ef2 61 fields · synced Oct 6, 2026