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Laryngeal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PA010215Model Silicone Reinforced
Identity
- Trade Name
- Laryngeal Mask EUDAMEDLaryngeal Mask, Silicone Reinforced, Size 1.5 FDA UDI
- Generic Name
- Reinforced laryngeal mask airway, single-use FDA UDI
- Device Name
- Laryngeal Mask EUDAMED
- Model / Reference
- Silicone Reinforced EUDAMEDPA010215 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PA010215 FDA UDI
- Primary DI / UDI-DI
- 06923310903417 EUDAMEDFDA UDI
- Basic UDI-DI
- 69233109PA010283 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
- GMDN Term
- Reinforced laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Laryngeal Mask by Hangzhou Formed Medical Devices Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69233109PA010283 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 4a2a6ffd-e72c-4cc0-9cfb-521b0f10fb64 61 fields · synced Jul 9, 2026
- FDA UDI 6d8b26c2-fe2c-417f-848f-e7910413b56e 33 fields · synced May 30, 2026