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LED DayLite Dental UltraMini Standard Imaging Basic
EUDAMEDClass I (EU MDR)
Ref 4929-3003-1012
Identity
- Device Name
- LED DayLite Dental UltraMini Standard Imaging Basic EUDAMED
- Model / Reference
- 4929-3003-1012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810070570194 EUDAMED
- Basic UDI-DI
- 081007057LED13TE EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LED DayLite Dental UltraMini Standard Imaging Basic by Designs for Vision, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081007057LED13TE | Class I | Active |
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Manufacturer
- Manufacturer
- Designs for Vision, Inc.
- EUDAMED SRN
- US-MF-000013810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 83e5693f-2b98-46fe-b7f7-9b29c0d7f4c6 61 fields · synced Jul 30, 2026