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ActivSight C-Mount Imaging Module
EUDAMEDClass IIa (EU MDR)
Ref AS-IM001Model AS-LE001
Identity
- Trade Name
- ActivSight C-Mount Imaging Module EUDAMED
- Device Name
- ActivSight Light Engine EUDAMED
- Model / Reference
- AS-LE001 EUDAMEDAS-IM001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850016403018 EUDAMED
- Basic UDI-DI
- 0850016403AS001EQ EUDAMED
- Direct Marketing DI
- 00850016403018 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 C-Mount Imaging Module 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 ea674bc2-ea9a-48f1-8e1a-b889123c13c5 61 fields · synced Aug 3, 2026