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Laryngeal Mask Airways for Single Use
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LMA1035210
Identity
- Trade Name
- Laryngeal Mask Airways for Single Use EUDAMEDUltra TC FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- Laryngeal Mask Airways for Single Use EUDAMEDLaryngeal Mask Airway Silicone Size 1.0 FDA UDI
- Model / Reference
- LMA1035210 EUDAMEDSize 1.0 FDA UDI
- Description
- Laryngeal Mask Airway Silicone Size 1.0 FDA UDI
Identifiers
- Catalog Number
- 1035210 FDA UDI
- Primary DI / UDI-DI
- 06970888440257 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970888440257 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-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
- 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
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
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-06970888440257 | 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 8fc0aa1e-5842-46f7-ae1f-a6fde40d4522 61 fields · synced Jun 18, 2026
- FDA UDI 115285a5-e5b0-4c22-9ea2-97ef6971c642 34 fields · synced May 30, 2026