Identity
- Trade Name
- Optical Assy, LED DayLite T-mount EUDAMED
- Device Name
- Optical Assy, LED DayLite T-mount EUDAMED
- Model / Reference
- 4708-0008-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810070572259 EUDAMED
- Basic UDI-DI
- 081007057LED71TU 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
Optical Assy, LED DayLite T-mount 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 | 081007057LED71TU | 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 fcb5cbbe-0201-4691-8a90-fbebe1faa123 61 fields · synced Jul 9, 2026