Identity
- Trade Name
- 25GA ACTU8 Talon ILM Forceps EUDAMEDVortex Surgical Inc. FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
- Device Name
- Forceps Devices EUDAMED25ga ACTU8 Talon ILM Forceps FDA UDI
- Model / Reference
- VS0752.25 EUDAMEDFDA UDI
- Description
- 25ga ACTU8 Talon ILM Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123481859 EUDAMEDFDA UDI
- Basic UDI-DI
- 081012348Forceps9G EUDAMED
- Unit of Use DI
- 00810123481835 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- Q021102 OPHTHALMIC SURGERY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
25GA ACTU8 Talon ILM Forceps 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 | 081012348Forceps9G | 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 640fddc6-c81f-4349-bd92-fdd855863fa3 61 fields · synced Jun 20, 2026
- FDA UDI e7921961-7a3b-4f0e-a3d5-4236782ee733 33 fields · synced May 30, 2026