Identity
- Device Name
- Light source EUDAMED
- Model / Reference
- E.8230.35 LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049047657538 EUDAMED
- Basic UDI-DI
- 4049047ZAD15AAA27DREP7 EUDAMED
- Direct Marketing DI
- 04049047657538 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Category: Endoscopic light source unit, line-powered
Light source by Gimmi Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4049047ZAD15AAA27DREP7 | Class I | Active |
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Manufacturer
- Manufacturer
- Gimmi GmbH
- EUDAMED SRN
- DE-MF-000005445
Sources (1)
- EUDAMED 5983e9e2-b515-4f56-8772-7e0c90b9663d 61 fields · synced Aug 4, 2026