Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040449

FEI Number

3002501070

Entity Name

OPHTEC BV

City/State/Country

GRONINGEN, NL

Establishment Address

SCHWEITZERLAAN 15, GRONINGEN 9728 NR, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPHTEC USA (Owner Number: 8040449)

Owner / Operator Contact Address

400 sawgrass corporate pkwy, Sunrise, FL 33325, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P030023

All Registered Proprietary Names

Artiflex Myopia Phakic Lens Veriflex Myopia Phakic Lens Verisyse Myopia Phakic Lens Artisan Myopia Phakic Lens ARTISAN Enclavation Forceps Artifix Holding Forceps ARTISAN Implantation Forceps Artisan - Artiflex Enclavation Needle Verisyse - Veriflex Enclavation Needle RingJect StabilEyes Capsular Tension Ring Ophtec Capsular Tension Ring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MTA	Lens, Intraocular, Phakic	Unknown	Class 3	N/A	2004-12-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-06-30
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-12-05
MRJ	Ring, Endocapsular	Unknown	Class 3	N/A	2007-12-05

Official Correspondent

William Rosero

US Agent Details

William Rosero Email: info@usa.ophtec.com Phone: (877) 2042275

Related Public Records

Same Entity

OPHTEC USA

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040449. Last updated year: 2026. Please use registration number 8040449 when referencing this establishment in official correspondence.