← Back to catalogue
Cleaning and reprocessing products
EUDAMEDFDA UDIClass I (EU MDR)
Ref 163951Model 10000201159
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Luer/non-ISO80369-standardized linear connector, reusable FDA UDI
- Device Name
- Cleaning and reprocessing products EUDAMEDIRRIGATION ADAPTER for motor handpiece 8564.021, reusable FDA UDI
- Model / Reference
- 10000201159 EUDAMED163951 EUDAMEDFDA UDI
- Description
- IRRIGATION ADAPTER for motor handpiece 8564.021, reusable FDA UDI
Identifiers
- Catalog Number
- 163951 FDA UDI
- Primary DI / UDI-DI
- 04055207064511 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520726032020-0017806E4 EUDAMED
- Direct Marketing DI
- 04055207064511 EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- Z12011399 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Luer/non-ISO80369-standardized linear connector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization 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 | 405520726032020-0017806E4 | 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
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED dfe48e26-c85f-45f1-a148-997a79a8e317 61 fields · synced Jun 19, 2026
- FDA UDI 05ccd924-f5fa-4c2a-a9bf-73fa2b3ed7ce 35 fields · synced May 30, 2026