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PENTAX Medical Video PROCESSOR EPK-3000
EUDAMEDClass IIa (EU MDR)
Ref 6217001P208SModel EPK-3000
Identity
- Trade Name
- PENTAX Medical Video PROCESSOR EPK-3000 EUDAMED
- Device Name
- PENTAX Medical Video PROCESSOR EPK-3000 EUDAMED
- Model / Reference
- EPK-3000 EUDAMED6217001P208S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04961333225255 EUDAMED
- Basic UDI-DI
- B-04961333225255 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
PENTAX Medical Video PROCESSOR EPK-3000 by HOYA Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04961333225255 | Class IIa | 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 200f43d7-adc8-4be8-81bf-c3e5a1dde9c3 61 fields · synced Jun 18, 2026