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Valve Kit for PENTAX
EUDAMEDClass I (EU MDR)
Ref AWV-KIT-03-PXRef BP-40060062Ref BP-40060065Ref AWV-KIT-01-PXRef BP-40060061
Identity
- Trade Name
- Valve Kit for PENTAX EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- AWV-KIT-03-PX EUDAMEDBP-40060062 EUDAMEDBP-40060065 EUDAMEDAWV-KIT-01-PX EUDAMEDBP-40060061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970900859890 EUDAMED06936603216651 EUDAMED06936603216668 EUDAMED06970900851368 EUDAMED06936603216644 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06970900859890 EUDAMED06936603216651 EUDAMED06936603216668 EUDAMED06970900851368 EUDAMED06936603216644 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 PENTAX by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (5)
- EUDAMED 4b764bac-88cf-4227-8081-40c29d622841 61 fields · synced Jul 23, 2026
- EUDAMED cab6b8cc-57ed-403d-9f2b-93b55555a0a2 61 fields · synced May 17, 2026
- EUDAMED 0dde1105-dacc-4924-8b3b-57b07d7fe6de 61 fields · synced May 18, 2026
- EUDAMED 1dd7039b-3ceb-46ca-8256-c18c9666752d 61 fields · synced May 18, 2026
- EUDAMED e5c035d0-393c-487b-a312-366ef89a13f9 61 fields · synced May 18, 2026