PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS3022A
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS3022A EUDAMEDPENTAX Medical FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- PENTAX Medical Cleaning Brush EUDAMEDPENTAX Medical PROfILE Single-Use Cleaning Brush FDA UDI
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001T007S EUDAMEDCS3022A FDA UDI
- Description
- PENTAX Medical PROfILE Single-Use Cleaning Brush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333221608 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333010507YC EUDAMED
- Unit of Use DI
- 84961333221604 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument/endoscope cleaning utensil, single-use
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS3022A by HOYA Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4961333010507YC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 46e5ab1d-7658-41b8-baa0-0005d19c8770 61 fields · synced Jun 19, 2026
- FDA UDI 56f2bc70-ca33-4f58-8ecb-ef8a1c174ab4 33 fields · synced May 30, 2026