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PENTAX Medical Video Bronchoscope EB11-J10
EUDAMEDClass IIa (EU MDR)
Ref 6217001S252SModel EB11-J10
Identity
- Trade Name
- PENTAX Medical Video Bronchoscope EB11-J10 EUDAMED
- Device Name
- PENTAX Medical Video Bronchoscope EB11-J10 EUDAMED
- Model / Reference
- EB11-J10 EUDAMED6217001S252S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04961333245833 EUDAMED
- Basic UDI-DI
- 4961333010101XC EUDAMED
- Direct Marketing DI
- 04961333245796 EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES 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 Bronchoscope EB11-J10 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 | 4961333010101XC | 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 9a102f26-5852-417a-9215-8c7b736a4e42 61 fields · synced Jun 20, 2026