Laryseal MRI Laryngeal Mask Airway Size 2.5
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Flexicare EUDAMEDLaryseal MRI Laryngeal Mask Airway Size 2.5 FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- Laryngeal Mask Airways EUDAMED
- Model / Reference
- 038-94-425U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788733638 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788733638 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN 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
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Laryngeal mask airway, single-use
Laryseal MRI Laryngeal Mask Airway Size 2.5 by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI 81357d9b-b569-4e98-b330-dc3faf0840e7 32 fields · synced Oct 7, 2026
- EUDAMED 7c13a8da-f0c2-4cf9-81e6-694ddd05eff4 61 fields · synced Oct 7, 2026