Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012481881

FEI Number

3012481881

Entity Name

AKTIVE SRL

City/State/Country

Rome Lazio, IT

Establishment Address

VIA GIACOMO DELITALA, 106, Rome Lazio 00173, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AKTIVE SRL (Owner Number: 10087294)

Owner / Operator Contact Address

VIA GIACOMO DELITALA, 106, Rome, IT-62 00173, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TWEEZER GRIP 20G Retinal Tip 20G Microforceps end-gripping TWEEZER GRIP 27G (37 mm) Retinal Tip 20G Microforceps crocodile teeth TWEEZER JAWS 27G Retinal Tip 25G Microforceps crocodile teeth TWEEZER JAWS 23G (37 mm) TWEEZER JAWS 23G Retinal Tip 25G Microforceps end-gripping TWEEZER GRIP 23G (37 mm) TWEEZER GRIP 25G TWEEZER ASYMMETRICAL 27G TWEEZER GRIP 27G TWEEZER JAWS 20G TWEEZER JAWS 25G TWEEZER JAWS 25G (37 mm) Retinal Tip 23G Microforceps crocodile teeth TWEEZER ASYMMETRICAL 20G Retinal Tip 23G Microforceps end-gripping TWEEZER GRIP ASYMMETRICAL 23G TWEEZER GRIP 23G TWEEZER FOREIGN BODY 20G TWEEZER GRIP 20G (37 mm) TWEEZER GRIP ASYMMETRICAL 25G TWEEZER JAWS 27G (37mm) TWEEZER GRIP 25G (37 mm) TWEEZER GRIP 25G (45mm) TWEEZER GRIP 25G TWEEZER GRIP 23G TWEEZER CUT VERTICAL 23G TWEEZER JAWS 23G TWEEZER GRIP 27G TWEEZER CUT STRAIGHT 20G TWEEZER CUT VERTICAL 25G TWEEZER Asymmetrical 27G TWEEZER CUT STRAIGHT 23G TWEEZER GRIP 20G (37 mm) Retinal Tip 20G Microscissors Curved Retinal Tip vertical 25G TWEEZER CUT STRAIGHT 25G Retinal Tip vertical 20G TWEEZER JAWS 25G TWEEZER GRIP ASYmmETRICAL 25G TWEEZER CUT CURVED 25G TWEEZER GRIP 25G (45mm) TWEEZER FOREIGN BODY 20G TWEEZER GRIP 25G (37 mm) TWEEZER JAWS 23G (37 mm) TWEEZER CUT VERTICAL 27G Retinal Tip 23G Microscissors Curved TWEEZER CUT VERTICAL 20G TWEEZER JAWS 20G TWEEZER CUT CURVED 20G Retinal Tip 23G Microscissors Straight TWEEZER CUT CURVED 27G TWEEZER CUT CURVED 23G Retinal Tip 25G Microscissors Straight Retinal Tip 20G Microscissors Straight TWEEZER GRIP 27G (37 mm) TWEEZER JAWS 25G (37 mm) TWEEZER CUT STRAIGHT 27G Retinal Tip 25G Microscissors Curved TWEEZER GRIP 23G (37 mm) TWEEZER ASYmmETRICAL 20G TWEEZER JAWS 27G TWEEZER GRIP ASYmmETRICAL 23G TWEEZER GRIP 20G TWEEZER JAWS 27G (37mm) Retinal Tip vertical 23G Full Handle Backflush 27G Soft tip Active/Passive (1,5 mm) Infusion/Aspiration tubing D1 Full Handle Backflush 23G Brush tip Extensible Active/Passive Assisted Infusion set K1 Air/fluid tubing A2 High pressure injection/aspiration system for syringe - Connector H Full Handle Backflush 20G Brush tip Extensible Active/Passive Infusion/Aspiration tubing D3 High pressure injection/aspiration system for syringe - Connector C Full Handle Backflush 27G Soft tip Active/Passive High pressure injection/aspiration system for syringe - Connector G (G2) High pressure injection/aspiration system with syringe - Connector E High pressure injection/aspiration system for syringe - Connector D High pressure injection/aspiration system for syringe - Connector F (F2) High pressure injection/aspiration system for syringe - Connector C (C2) Dual Bore Cannula 20G Tubing set D4 High pressure injection/aspiration system with syringe - Connector A Air injection tube 200 cm Set Bi-manual I/A Handpieces 23G Full Handle Backflush 27G Soft tip Extensible Active/Passive Infusion/Aspiration tubing A1 Full Handle Backflush 25G Soft tip Active/Passive High pressure injection/aspiration system for syringe - Connector D (D2) Full Handle Backflush 25G Brush tip Extensible Active/Passive Tubing set D5 Dual Bore Cannula 27G High pressure injection/aspiration system for syringe - Connector E Tubing set A4 Full Handle Backflush 23G Soft tip Active/Passive Full Handle Backflush 27G Brush tip Active/Passive Tubing set D7 High pressure injection/aspiration system for syringe - Connector H(H2) High pressure injection/aspiration system with syringe - Connector D High pressure injection/aspiration system for syringe - Connector A Air injection tube 70 cm Full Handle Backflush 23G Brush tip Active/Passive High pressure injection/aspiration system with syringe - Connector H High pressure injection/aspiration system with syringe - Connector F Full Handle Backflush 23G Soft tip Extensible Active/Passive Passive Reservoir Full Handle Backflush 20G Soft tip Extensible Active/Passive Tubing set A5 Assisted Infusion set D2 Full Handle Backflush 25G Standard Active/Passive Full Handle Backflush 20G Soft tip Active/Passive High pressure injection/aspiration system with syringe - Connector C High pressure injection/aspiration system with syringe - Connector B Assisted Infusion set A3 Dual Bore Cannula 25G, 36mm Full Handle Backflush 23G Standard Active/Passive Full Handle Backflush 20G Brush tip Active/Passive Full Handle Backflush 27G Brush tip Active/Passive (1,5 mm) Full Handle Backflush 23G Brush tip Active/Passive (1,5 mm) Full Handle Backflush 23G Soft tip Active/Passive (1.5 mm) Air/fluid tubing D8 Full Handle Backflush 25G Brush tip Active/Passive Full Handle Backflush 25G Soft tip Active/Passive (1,5 mm) Dual Bore Cannula 23G, 36mm Full Handle Backflush 27G Standard Active/Passive Full Handle Backflush 25G Brush tip Active/Passive (1,5 mm) Full Handle Backflush 27G Brush tip Extensible Active/Passive High pressure injection/aspiration system for syringe - Connector F Dual Bore Cannula 25G Full Handle Backflush 25G Soft tip Extensible Active/Passive Tubing set D6 Full Handle Backflush 20G Standard Active/Passive High pressure injection/aspiration system with syringe - Connector G Set Bi-Manual I/A Handpieces 21G Active Reservoir High pressure injection/aspiration system for syringe - Connector G High pressure injection/aspiration system for syringe - Connector B (B2) High pressure injection/aspiration system for syringe - Connector B High pressure injection/aspiration system for syringe - Connector A (A2) Air injection tube 140 cm High pressure injection/aspiration system for syringe - Connector E (E2) Dual Bore Cannula 23G Infusion Cannula 20G, 2,5 mm Charles Cannula Soft Tip 25G Atkinson Tip Peribulbar Needle 23G x22 mm Charles Cannula Soft Tip 25G (1,5mm) Charles Cannula Soft Tip 23G Lacrimal Cannula Curved 23Gx28mm Charles Cannula Soft Tip 23G, 36mm Mantainer anterior chamber 23G, spatula Retrobulbar Needle Atkinson 27G x 38mm Anterior Chamber Irrigator Visco Cannula 27G x 22mm Anterior Chamber Cannula Rycroft 27G X 22mm Peri-Retrobulbar Needle Atkinson 23G x 32mm Charles Cannula Standard 29G Silicone Oil Infusion Cannula 20G, 4,0mm Subretinal injection needle 23G tapered to 38G complete with handpiece Mantainer anterior chamber 23G Charles Cannula Brush Tip 27G 36 mm Charles Cannula Standard 27G, 36mm I & A Cannula Simcoe Regular 23Gx23G 0.3 mm Port, Curved Viscocanalostomy Cannula 27G Open End Curved Irrigation Cannula 23G with 3 lateral holes Infusion Line Silicone 20G 4mm for Trocar universal Charles Cannula Brush 25G Anterior Chamber Irrigation Cannula 20Gx22mm Charles Cannula Soft Tip 27G (1,5mm) Charles Cannula Standard 25G Needle 30G x 12,7 mm Charles Cannula Brush Tip 27G Charles Cannula Soft Tip 27G, 36mm Retrobulbar needle 27Gax32mm Atkinson tip Subretinal injection needle 25G tapered to 38G complete with handpiece Charles Cannula Brush 23G Charles Cannula Standard 20G Charles Cannula Standard 23G, 36mm Mantainer anterior chamber 18G Nucleus Hydrodissection Cannula 27G x22 mm - Curved Sauter Charles Cannula Soft Tip 25G, 36 mm Visco Fluid Cannula 27G Silicone Oil Infusion Line 23G for Tocar Mantainer anterior chamber 20G Charles Cannula Brush tip 23G,36 mm Atkinson Tip Peribulbar Needle 25G x 22 mm Nucleus Hydrodissection Cannula 25G x 22 mm- Curved Horizontal Lacrimal Cannula 21G x 28 mm Straight Cortex Extractor Cannula Simcoe 13 mm CAPSULE POLISHER JENSON OLIVE TIP 28mm CURVED 25G Infusion Needle 20G Nucleus Hydrodissection Cannula 27G x 22 mm- Curved Horizontal Lacrimal Cannula 26G x 28 mm Charles Cannula Standard 27G Subretinal injection needle 27G tapered to 38G complete with handpiece Retrobulbar Needle Atkinson 23G x 38mm Atkinson Tip Peribulbar Needle 27G x22 mm Infusion Cannula 20G, 6,0 mm Subtenon's Cannula 19G 25mm Visco Fluid Cannula 25G Charles Cannula Soft Tip 23G (1,5mm) Aspiration Cannula 21G Lacrimal Cannula 23Gx28 mm Straight Charles Cannula Brush 20G Charles Cannula Soft Tip 27G Anterior chamber irrigation Cannula Ang. 12 mm 25Gx22mm Charles Cannula Soft Tip 20G Infusion Cannula 20G, 4,0 mm Charles Cannula Standard 25G,36 mm Nucleus Hydrodissection Cannula Ang. 35, 27G x 22 mm Anterior Chamber Irrigation Cannula 25Gx22mm Lacrimal Cannula 21G x 28 mm Curved Nucleus Hydrodissection Cannula 25G x 22 mm Angled 35 Mantainer anterior chamber 25G Anterior Chamber Irrigation Cannula 30G Charles Cannula Brush 25G 36 mm Visco Fluid Cannula 23G Silicone Oil Infusion Line 25G for Trocar Charleaux Needle 25G Visco Fluid Cannula 20G Charles Cannula Standard 29G, 36mm Charles Cannula Standard 23G Silicone Oil Infusion Cannula 20G, 6mm Irrigaing Cystotome Formed 27G x 16mm Retrobulbar Needle Atkinson 25G x 38mm Trocar set 25G with removable valve Trocar 23G with removable valve Trocar 27G with removable valve Trocar 20g with removable valve Trocar set 20G with removable valve Trocar 25G with removable valve Trocar set 23G with removable valve Trocar set 27g with removable valve Set of 5 Iris Retractors Set of 4 Iris Retractors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-13
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-13
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2023-02-13
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-09
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-13
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2023-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

AKTIVE SRL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

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3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
9612278	DUFNER INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012481881. Last updated year: 2026. Please use registration number 3012481881 when referencing this establishment in official correspondence.