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Oropharyngeal Airway
EUDAMEDClass I (EU MDR)
Ref ROA0101005Model S40、S50、S60、S70、S80、S90、S100、S110、S40~S110
Identity
- Trade Name
- Oropharyngeal Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- S40、S50、S60、S70、S80、S90、S100、S110、S40~S110 EUDAMEDROA0101005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430414281 EUDAMED
- Basic UDI-DI
- 694643043130802N4 EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Oropharyngeal Airway by Xiamen Compower Medical Tech. 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 | 694643043130802N4 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 2e7635d2-c7c9-4e18-a32f-9448aceb96fa 61 fields · synced Jun 18, 2026