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cleaning and reprocessing products
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8691Model 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 For surface cleaning, straight, PACK=10 PCS, for single use FDA UDI
- Model / Reference
- 10000201116 EUDAMED8691 EUDAMEDFDA UDI
- Description
- CLEANING BRUSH For surface cleaning, straight, PACK=10 PCS, for single use FDA UDI
Identifiers
- Catalog Number
- 8691 FDA UDI
- Primary DI / UDI-DI
- 04055207064726 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017724PL EUDAMED
- Unit of Use DI
- 04055207064733 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
- Not 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
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 2eaf307b-2fe3-4030-9e60-5857daed1894 61 fields · synced Jun 19, 2026
- FDA UDI 766e2317-4cde-422d-9f6f-72b0e1abfccc 36 fields · synced May 30, 2026