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LED DayLite Surgical PowerPack Assy with Holster
EUDAMEDClass I (EU MDR)
Ref 4912-0001-0000
Identity
- Trade Name
- LED DayLite Surgical PowerPack Assy with Holster EUDAMED
- Device Name
- LED DayLite Surgical PowerPack Assy with Holster EUDAMED
- Model / Reference
- 4912-0001-0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810070571887 EUDAMED
- Basic UDI-DI
- 081007057LED47TX 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 Surgical PowerPack Assy with Holster 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 | 081007057LED47TX | 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 14c10d5e-bb3c-4d63-8bac-b9d0e77c87fe 61 fields · synced Jul 17, 2026