Identity
- Trade Name
- Laryngeal Mask EUDAMED
- Device Name
- Laryngeal Mask EUDAMED
- Model / Reference
- PVC Standard EUDAMEDPA020315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310904551 EUDAMED
- Basic UDI-DI
- 69233109PA020186 EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN 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
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
Discover the Laryngeal Mask, a Class IIa medical device designed for respiratory support. This device provides a secure and comfortable airway solution for patients undergoing surgery or requiring prolonged mechanical ventilation.
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 | 69233109PA020186 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b1461838-eac7-44db-b418-dd602ff0651c 61 fields · synced Jun 21, 2026