Identity
- Trade Name
- 23ga Flex-Tip Laser Probe- Oertli EUDAMED
- Device Name
- Laser Probe and Illumination Devices EUDAMED
- Model / Reference
- VK401113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810123483792 EUDAMED
- Basic UDI-DI
- 081012348LaserDX EUDAMED
- Unit of Use DI
- 00810123483716 EUDAMED
- EMDN Code
- Q02040301 OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
23ga Flex-Tip Laser Probe- Oertli by Vortex 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 | 081012348LaserDX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vortex Surgical Inc
- EUDAMED SRN
- US-MF-000022888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5aaa0980-ece0-4626-8745-32fb22376d68 61 fields · synced Jun 19, 2026