Identity
- Trade Name
- Reusable Channel Cleaning Brush EUDAMED8000 Series Reusable Channel Cleaning Brush FDA UDI
- Generic Name
- Endoscope cleaning brush, reusable FDA UDI
- Device Name
- Reusable and Disposable Cleaning Brushes EUDAMEDReusable Channel Cleaning Micro Brush. HIBC/UPN: M45387030 FDA UDI
- Model / Reference
- 8703 EUDAMEDFDA UDI
- Description
- Reusable Channel Cleaning Micro Brush. HIBC/UPN: M45387030 FDA UDI
Identifiers
- Catalog Number
- 8703 FDA UDI
- Primary DI / UDI-DI
- M45387030 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M453RCBWY EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070102 DIGESTIVE ENDOSCOPY ENDOSCOPES CLEANING BRUSHES EUDAMED
- GMDN Term
- Endoscope cleaning brush, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Reusable Channel Cleaning Brush by Primed Instruments Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M453RCBWY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PriMed Instruments Inc.
- EUDAMED SRN
- CA-MF-000002760
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e7ca33a7-3e3c-4012-b225-f2222f5856db 61 fields · synced May 30, 2026
- FDA UDI 28000fc2-d0fa-4db0-8c49-b5ea435c77bb 37 fields · synced May 24, 2026