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Medocare Guedel Airway
EUDAMEDClass I (EU MDR)
Ref 8906012464761Model Guedel Type: 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm
Identity
- Trade Name
- Medocare Guedel Airway EUDAMED
- Device Name
- Oropharyngeal Airways EUDAMED
- Model / Reference
- Guedel Type: 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm EUDAMED8906012464761 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382603032 EUDAMED
- Basic UDI-DI
- 697209192OPA11JP EUDAMED
- Direct Marketing DI
- 06942382603032 EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Medocare Guedel Airway by Bonree Medical Co., Ltd. — Class I — 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 | 697209192OPA11JP | Class I | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d8a5ae42-bb81-4eab-8257-7f70c92186a9 61 fields · synced Jun 18, 2026