Data / Medical devices / Netherlands / Vitreq BV

Vitreq BV: FDA-registered device maker in Vierpolders Zuid-Holland, Netherlands, 2 510(k) clearances

Name: Vitreq BV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vitreq BV is registered with the FDA (registration 3012037425) in Vierpolders Zuid-Holland, Netherlands. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 30, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012037425
Address: Seggelant-Noord 2, Vierpolders Zuid-Holland, Netherlands, 3237 MG
Owner or operator: VITREQ BV (10050448)
Roles: Manufacturer, Specification developer
First device listed: November 18, 2015
Registered through: 2027
Brand names listed: CryoTreQ, Depressor, orbital, FORCEPS, OPHTHALMIC, Spatula, Ophthalmic, VITREQ Cannula, VITREQ Needle, VITREQ Scissors, VitreQ Chandelier & Light Fibers and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Manufacturer, Specification developer	accessdata.fda.gov
Depressor, Orbital	HNX	1	Manufacturer	accessdata.fda.gov
Endoilluminator	MPA	2	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Manufacturer	accessdata.fda.gov
Unit, Cryophthalmic	HPS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 30, 2020	K202038	CryoTreQ	HPS	Substantially Equivalent	VitreQ BV	accessdata.fda.gov
May 1, 2019	K182646	Vitreq disposable laser probes, light fibers and Chandelier	HQB	Substantially Equivalent	VitreQ BV	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 17, 2019	84661	Class II	Terminated	(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140	Microscopic tears of the sterile pouch may compromise sterility	accessdata.fda.gov

Compare with other makers

Updated December 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.