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PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A
EUDAMEDClass I (EU MDR)
Ref 6217001T007SModel See UDI-DI information for model names
Identity
- Trade Name
- PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A EUDAMED
- Device Name
- PENTAX Medical Cleaning Brush EUDAMED
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001T007S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14961333228796 EUDAMED
- Basic UDI-DI
- 4961333010507YC EUDAMED
- Unit of Use DI
- 04961333221639 EUDAMED
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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: Surgical instrument/endoscope cleaning utensil, single-use
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A by HOYA Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
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 | 4961333010507YC | 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 90c4e6a0-bf58-4e19-a7c0-5bf95b73ff7d 61 fields · synced Jun 19, 2026