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Oropharyngeal Airway
EUDAMEDClass I (EU MDR)
Ref ROA0102008Model Z40、Z50、Z60、Z70、Z80、Z90、Z100、Z110、Z120、Z40～Z110、Z40～Z120
Identity
- Trade Name
- Oropharyngeal Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- Z40、Z50、Z60、Z70、Z80、Z90、Z100、Z110、Z120、Z40～Z110、Z40～Z120 EUDAMEDROA0102008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430414137 EUDAMED
- Basic UDI-DI
- 694643043130801N2 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 | 694643043130801N2 | 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 8c805808-85bb-4c7f-b969-efc1bd450bf8 61 fields · synced Jun 19, 2026