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Laryngeal Mask Airways for Single Use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LMA1037240
Identity
- Trade Name
- Laryngeal Mask Airways for Single Use EUDAMEDUltra Flex TC FDA UDI
- Generic Name
- Reinforced laryngeal mask airway, single-use FDA UDI
- Device Name
- Laryngeal Mask Airways for Single Use EUDAMEDLaryngeal Mask Airway Silicone Wire Reinforced Size 4.0 FDA UDI
- Model / Reference
- LMA1037240 EUDAMEDSize 4.0 FDA UDI
- Description
- Laryngeal Mask Airway Silicone Wire Reinforced Size 4.0 FDA UDI
Identifiers
- Catalog Number
- 1037240 FDA UDI
- Primary DI / UDI-DI
- 06970888440387 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970888440387 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-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
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Laryngeal mask airway, single-use
Laryngeal Mask Airways for Single Use by Yiles Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970888440387 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Yiles Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039481
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 45c911e2-bc08-4d66-a490-a78f8dfc921f 61 fields · synced Jul 24, 2026
- FDA UDI d2d636f3-d330-47d8-9365-49af6cd4e578 34 fields · synced May 30, 2026