Identity
- Trade Name
- 23GA Flex-Tip Laser Probe EUDAMEDVortex Surgical Inc FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- Laser Probe and Illumination Devices EUDAMED23ga Flex-Tip Laser Probe FDA UDI
- Model / Reference
- VS0130.23 EUDAMEDFDA UDI
- Description
- 23ga Flex-Tip Laser Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123480258 EUDAMEDFDA UDI
- Basic UDI-DI
- 081012348LaserDX EUDAMED
- Unit of Use DI
- 00810123480104 EUDAMED
- FDA Product Code
- HQB FDA UDI
- EMDN Code
- Q02040301 OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4690 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
23GA Flex-Tip Laser Probe by Vortex Surgical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081012348LaserDX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vortex Surgical Inc
- EUDAMED SRN
- US-MF-000022888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c05bfa21-b5bb-4dc9-a756-471bb61e4e84 61 fields · synced Jul 17, 2026
- FDA UDI c7046e85-1a64-49b2-8385-b5897fd4f72d 33 fields · synced May 30, 2026