Identity
- Trade Name
- Adult Bite Block EUDAMED
- Device Name
- Disposable Bite Blocks EUDAMED
- Model / Reference
- BP-40402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603220962 EUDAMED
- Basic UDI-DI
- 69709008510047V EUDAMED
- Direct Marketing DI
- 06936603220962 EUDAMED
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS 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
Adult Bite Block by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — CE/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 | 69709008510047V | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED c8d8c3a8-e0c8-4ac3-90cf-307d648f64e0 61 fields · synced Oct 6, 2026