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EinsteinVision®
EUDAMEDClass IIa (EU MDR)
Ref PV661Model 3D NIR Videolaparoscopes
Identity
- Trade Name
- EinsteinVision® EUDAMED
- Model / Reference
- 3D NIR Videolaparoscopes EUDAMEDPV661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480104514 EUDAMED
- Basic UDI-DI
- 425048013DNIRVIDEOLAPSU8 EUDAMED
- Direct Marketing DI
- 04250480104514 EUDAMED
- EMDN Code
- Z12029016 VIDEO LAPAROSCOPES 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
EinsteinVision® by SCHÖLLY FIBEROPTIC GmbH — 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 | 425048013DNIRVIDEOLAPSU8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED 266df5d5-2d93-460e-92c8-9a2ae99b3b3b 61 fields · synced Jul 13, 2026