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27GA MAXReach Laser Probe
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref VS0140.27
Identity
- Trade Name
- 27GA MAXReach Laser Probe EUDAMEDVortex Surgical Inc FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- Laser Probe and Illumination Devices EUDAMED27ga MAX Reach Laser Probe FDA UDI
- Model / Reference
- VS0140.27 EUDAMEDFDA UDI
- Description
- 27ga MAX Reach Laser Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123480296 EUDAMEDFDA UDI
- Basic UDI-DI
- 081012348LaserDX EUDAMED
- Unit of Use DI
- 00810123480142 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
27GA MAXReach Laser Probe by Vortex Surgical, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191846 | Class IIa | Active |
| 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 (3)
- EUDAMED ed0a3a96-95c8-4241-9a69-aebd417ff719 61 fields · synced Jul 14, 2026
- FDA UDI 6cfae3f4-539e-4260-b0c8-e32b452a3ac6 33 fields · synced May 30, 2026
- FDA 510(k) K191846 1 fields · synced May 18, 2026