← Back to catalogue
Laryseal Flexi Laryngeal Mask Airway Size 2.5
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 038-94-525U
Identity
- Trade Name
- Flexicare EUDAMEDLaryseal Flexi 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
- 038-94-525U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788733416 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788733416 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
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
Yes
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
Category: Laryngeal mask airway, single-use
Laryseal Flexi Laryngeal Mask Airway Size 2.5 by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Laryngeal mask airway, single-use.
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
- LMA — TELEFLEX INCORPORATED · Class I
- I-GEL PLUS, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG — Intersurgical Incorporated · Class I
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
- LMA AIRWAY MANAGEMENT — TELEFLEX INCORPORATED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI 9a73fc3f-3210-4122-9c9a-a8c9af341a8a 32 fields · synced Oct 7, 2026
- EUDAMED 8af7f2cc-14b0-46ea-aae6-17117b2c1f13 61 fields · synced Oct 7, 2026