Identity
- Trade Name
- ActivSight Light Engine EUDAMED
- Device Name
- ActivSight Light Engine EUDAMED
- Model / Reference
- AS-LE001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850016403001 EUDAMED
- Basic UDI-DI
- 0850016403AS001EQ EUDAMED
- Direct Marketing DI
- 00850016403001 EUDAMED
- EMDN Code
- Z12029007 INFRA–RED SURGICAL ILLUMINATORS EUDAMED
Classification
- Device Class
- Class IIa 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
ActivSight Light Engine by Activ Surgical, Inc. — Class IIa — 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 | 0850016403AS001EQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Activ Surgical, Inc.
- EUDAMED SRN
- US-MF-000019220
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3234a168-eb04-4bbf-a7fe-e4617e509ccb 61 fields · synced Jul 9, 2026