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PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215
EUDAMEDClass I (EU MDR)
Ref 6217001T012SModel OF-B215
Identity
- Trade Name
- PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215 EUDAMED
- Device Name
- PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215 EUDAMED
- Model / Reference
- OF-B215 EUDAMED6217001T012S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14961333226167 EUDAMED
- Basic UDI-DI
- B-14961333226167 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastro-urological guidewire, single-use
PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215 by HOYA Corporation — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14961333226167 | Class I | Active |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (1)
- EUDAMED 81d7eed8-d006-4d70-94fe-23fa4addbef0 61 fields · synced Oct 7, 2026