← Back to catalogue
23GA Illuminated Flex-Tip Laser Probes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VS0135.23
Identity
- Trade Name
- 23GA Illuminated Flex-Tip Laser Probes EUDAMEDVortex Surgical Inc. FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- Laser Probe and Illumination Devices EUDAMED23ga Illuminated Flex-Tip Laser Probe FDA UDI
- Model / Reference
- VS0135.23 EUDAMEDFDA UDI
- Description
- 23ga Illuminated Flex-Tip Laser Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123483624 EUDAMEDFDA UDI
- Basic UDI-DI
- 081012348LaserDX EUDAMED
- Unit of Use DI
- 00810123483532 EUDAMED
- FDA Product Code
- HQB FDA UDIMPA 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 UDI876.1500 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
Yes
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 Illuminated Flex-Tip Laser Probes 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vortex Surgical Inc
- EUDAMED SRN
- US-MF-000022888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2691f2eb-048a-445d-9e0e-6438688636bc 61 fields · synced Jun 18, 2026
- FDA UDI fb160b64-bfe9-4efb-915f-05adf54645d8 33 fields · synced May 30, 2026