Identity
- Trade Name
- AMALIA 2 B S8 EUDAMED
- Device Name
- Examination light EUDAMED
- Model / Reference
- D16376000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640158713112 EUDAMED
- Basic UDI-DI
- 76401587118S 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
Amalia 2 B S8 by Derungs Licht AG — 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 | 76401587118S | Class I | Active |
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Manufacturer
- Manufacturer
- Derungs Licht AG
- EUDAMED SRN
- CH-MF-000015827
- Authorised Representative
- Derungs Medical GmbH DE-AR-000033841
Sources (1)
- EUDAMED aae892b1-d88e-45d3-98a8-255accdda3b6 61 fields · synced Jun 18, 2026