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Handheld remote controls for CCU
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5525401Model 10000201432
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscopic device remote control FDA UDI
- Device Name
- Handheld remote controls for CCU EUDAMEDMANUAL REMOTE CONTROL USB reusable FDA UDI
- Model / Reference
- 10000201432 EUDAMED5525401 EUDAMEDFDA UDI
- Description
- MANUAL REMOTE CONTROL USB reusable FDA UDI
Identifiers
- Catalog Number
- 5525401 FDA UDI
- Primary DI / UDI-DI
- 04055207000557 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520716052019-0027153L4 EUDAMED
- Direct Marketing DI
- 04055207000557 EUDAMED
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic device remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Handheld remote controls for CCU 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 | 405520716052019-0027153L4 | 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 35fb1035-ec28-4963-b1f5-716263e138c1 61 fields · synced Jun 19, 2026
- FDA UDI b1f30434-b212-431e-acc3-89697a836bae 35 fields · synced May 30, 2026