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Disposable laryngeal mask airway
EUDAMEDClass IIa (EU MDR)
Ref 98.01.001Model Single Lumen
Identity
- Trade Name
- Disposable laryngeal mask airway EUDAMED
- Device Name
- Disposable Laryngeal Mask Airway EUDAMED
- Model / Reference
- Single Lumen EUDAMED98.01.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973175660000 EUDAMED
- Basic UDI-DI
- 697317566CFZR010200ZD EUDAMED
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Disposable laryngeal mask airway by Hangzhou Trifanz Medical Device Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697317566CFZR010200ZD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Trifanz Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000034120
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b66fa3ef-5415-42d7-b750-0bd7f444c910 61 fields · synced Jun 19, 2026