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PENTAX Medical Video Colonoscope EC38-i10NF+
EUDAMEDClass IIa (EU MDR)
Ref 6217001S357S Model See UDI-DI information for model names
Identity
- Trade Name
- PENTAX Medical Video Colonoscope EC38-i10NF+ EUDAMED
- Device Name
- PENTAX Medical Video Colonoscope EUDAMED
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001S357S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04961333254286 EUDAMED
- Basic UDI-DI
- 4961333010102XE EUDAMED
- Direct Marketing DI
- 04961333254293 EUDAMED
- EMDN Code
- Z12020606 VIDEO COLONOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
PENTAX Medical Video Colonoscope EC38-i10NF+ by HOYA Corporation — Class IIa — 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 | 4961333010102XE | 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 e7fb6725-36ed-4d71-85e5-3d6d15bcca46 61 fields · synced Jul 10, 2026