Identity
- Trade Name
- Oropharyngeal Airway EUDAMED
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- TW8409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970385722719 EUDAMED
- Basic UDI-DI
- 697038572OA2J EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Tianzuo 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 | 697038572OA2J | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Tianzuo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018733
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED f2fd01af-d180-40d8-959d-9674b936f346 61 fields · synced Jun 17, 2026