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Disposable Video Laryngeal Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 02500060Model FlexiVIew
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- Disposable Video Laryngeal Mask EUDAMED
- Model / Reference
- FlexiVIew EUDAMED02500060 EUDAMEDFlexiView #2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974599110393 EUDAMEDFDA UDI
- Basic UDI-DI
- 697459911LaryngealMask1PH EUDAMED
- Unit of Use DI
- 86974599110399 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020199 LARYNGEAL MASKS - OTHER EUDAMED
- GMDN Term
- 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
- Türkiye 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
Yes
FDA UDI
Disposable Video Laryngeal Mask by Changsha Magill Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697459911LaryngealMask1PH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Changsha Magill Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012007
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 107c76a6-f401-4acf-bf55-90d2d3ef7606 61 fields · synced Jun 19, 2026
- FDA UDI 9df7f6b9-b105-4d96-8a00-8eca2243f485 33 fields · synced May 30, 2026