Identity
- Trade Name
- Cleaning Brush, Long, 12mm-20mm 3ea EUDAMEDCleaning Brush, Long FDA UDI
- Generic Name
- Airway device cleaning utensil, invasive FDA UDI
- Device Name
- CLEANINGBRUSH EUDAMED
- Model / Reference
- IN 4063 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- IN 4063 FDA UDI
- Primary DI / UDI-DI
- 00848253004020 EUDAMEDFDA UDI
- Basic UDI-DI
- 08482530CLEANINGBRUSH9F EUDAMED
- FDA Product Code
- EPE FDA UDI
- EMDN Code
- V070105 INSTRUMENTS CLEANING BRUSHES EUDAMED
- GMDN Term
- Airway device cleaning utensil, invasive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5795 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cleaning Brush, Long, 12mm-20mm 3ea by Freudenberg Medical LLC — 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 | 08482530CLEANINGBRUSH9F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Freudenberg Medical LLC
- EUDAMED SRN
- US-MF-000023823
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 07c41684-2f59-42b7-b0f3-6098ae69f1c0 61 fields · synced Jun 19, 2026
- FDA UDI d12f348a-29b3-4b1b-b8ae-990042320b17 34 fields · synced May 30, 2026