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cleaning and reprocessing products
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7970407Model 10000201116
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- cleaning and reprocessing products EUDAMEDCLEANING BRUSH Ø 7MM TL 400MM for channel Ø 4,6 - 6,5mm, brush length 48mm, PACK=10 PCS, color purple, for single use FDA UDI
- Model / Reference
- 10000201116 EUDAMED7970407 EUDAMEDFDA UDI
- Description
- CLEANING BRUSH Ø 7MM TL 400MM for channel Ø 4,6 - 6,5mm, brush length 48mm, PACK=10 PCS, color purple, for single use FDA UDI
Identifiers
- Catalog Number
- 7970407 FDA UDI
- Primary DI / UDI-DI
- 04055207064962 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017724PL EUDAMED
- Unit of Use DI
- 04055207064979 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- Z12011399 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - OTHER 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
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 7 Millimeter FDA UDILength — 400 Millimeter FDA UDI
cleaning and reprocessing products by Richard Wolf GmbH — 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 | 405520727052019-0017724PL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED dba3a7fd-5d11-462d-8509-ebf4981ff01d 61 fields · synced Jul 9, 2026
- FDA UDI 05398ca1-7610-4d32-8762-72e0b094a925 36 fields · synced May 30, 2026