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Valve Kit for FUJIFILM 500/600 Series Endoscopes
EUDAMEDClass I (EU MDR)
Ref BP-40060064Ref BP-40060063Ref AWV-KIT-03-FJ
Identity
- Trade Name
- Valve Kit for FUJIFILM 500/600 Series Endoscopes EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- BP-40060064 EUDAMEDBP-40060063 EUDAMEDAWV-KIT-03-FJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603216682 EUDAMED06936603216675 EUDAMED06970900852938 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603216682 EUDAMED06936603216675 EUDAMED06970900852938 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Gastro-urological guidewire, single-use
Valve Kit for FUJIFILM 500/600 Series Endoscopes by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR — listed in EUDAMED
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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 | 69709008510147Y | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED 89734736-629f-48d0-ace8-750b398b3dc2 61 fields · synced Jul 17, 2026
- EUDAMED ef7a19e0-b71a-449b-bc3a-9c753c195c82 61 fields · synced May 17, 2026
- EUDAMED 80766b07-4415-4c99-83f7-690cf7f98e65 61 fields · synced May 18, 2026