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25ga Intuitive Extendable MaxReach- Oertli
EUDAMEDClass IIa (EU MDR)
Ref VK401325
Identity
- Trade Name
- 25ga Intuitive Extendable MaxReach- Oertli EUDAMED
- Device Name
- Laser Probe and Illumination Devices EUDAMED
- Model / Reference
- VK401325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810123483853 EUDAMED
- Basic UDI-DI
- 081012348LaserDX EUDAMED
- Unit of Use DI
- 00810123483778 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
25ga Intuitive Extendable MaxReach- 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 a196319c-c2a0-4f1b-8459-1a2574cc6ed8 61 fields · synced Jul 17, 2026