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Oral-Pharyngeal Airway
EUDAMEDClass I (EU MDR)
Ref PA040204Model Berman airwayRef PA040209Ref PA040410Model Guedel AirwayRef PA040412Ref PA040405Ref PA040206Ref PA040205Ref PA040211
Identity
- Trade Name
- Oral-Pharyngeal Airway EUDAMED
- Device Name
- Oral-Pharyngeal Airway EUDAMED
- Model / Reference
- Berman airway EUDAMEDPA040204 EUDAMEDPA040209 EUDAMEDGuedel Airway EUDAMEDPA040410 EUDAMEDPA040412 EUDAMEDPA040405 EUDAMEDPA040206 EUDAMEDPA040205 EUDAMEDPA040211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310901208 EUDAMED06923310901253 EUDAMED06923310911153 EUDAMED06923310911177 EUDAMED06923310911108 EUDAMED06923310901222 EUDAMED06923310901215 EUDAMED06923310901277 EUDAMED
- Basic UDI-DI
- 69233109PA04028J EUDAMED69233109PA04018G EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Oral-Pharyngeal Airway by Hangzhou Formed Medical Devices 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 | 69233109PA04028J | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 3e729492-fb22-4ba1-9beb-afd4b97b934c 61 fields · synced Jul 26, 2026
- EUDAMED ac100820-bf69-434c-8285-d9142f1f99a6 61 fields · synced May 16, 2026
- EUDAMED b49c450b-3bef-4973-b501-2c6d2dcb58cb 61 fields · synced May 17, 2026
- EUDAMED 8366c10f-750d-4815-8ec2-e60a37bb8816 61 fields · synced May 17, 2026
- EUDAMED 35fe298d-033c-41e4-97be-bcaefa6c3498 61 fields · synced May 18, 2026
- EUDAMED 49651234-f50c-4e7a-a08d-1056f3240917 61 fields · synced May 18, 2026
- EUDAMED 81c4654c-82e0-43be-9454-69eccbe3bba2 61 fields · synced May 18, 2026
- EUDAMED 1da0256d-a49f-47c0-8149-19cd49badb35 61 fields · synced May 18, 2026