Identity
- Trade Name
- D25+ EUDAMEDUV Smart FDA UDI
- Generic Name
- Ultraviolet ambient disinfection light FDA UDI
- Device Name
- UV Smart D25 EUDAMED
- Model / Reference
- V2 EUDAMEDD25 EUDAMEDD25V2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719326634265 EUDAMEDFDA UDI
- Basic UDI-DI
- 87193266342D253N EUDAMED
- Direct Marketing DI
- 08719326634265 EUDAMED
- FDA Product Code
- MEC FDA UDI
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
- GMDN Term
- Ultraviolet ambient disinfection light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6992 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
D25+ by UV Smart Technologies B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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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 | 87193266342D253N | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- UV Smart Technologies B.V.
- EUDAMED SRN
- NL-MF-000017126
Sources (2)
- EUDAMED e2feef25-d193-4d64-8ab7-2ad09cea4c3c 61 fields · synced Jul 30, 2026
- FDA UDI 45c49bd5-62c6-401b-93bc-9530bc99c261 32 fields · synced May 30, 2026