Data / Medical devices / Netherlands / Microtek Medical B.V.

Microtek Medical B.V.: FDA-registered device maker in Zutphen Gelderland, Netherlands, 2 510(k) clearances

Name: Microtek Medical B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Microtek Medical B.V. is registered with the FDA (registration 3006116468) in Zutphen Gelderland, Netherlands. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 1999. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006116468
Address: Hekkehorst 24, Zutphen Gelderland, Netherlands, 7207 BN
Owner or operator: Medline Industries, LP (1417592)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: October 20, 2014
Registered through: 2027
Brand names listed: AKTORmed, BEDDING, CleanOp: bedding and cleaning supplies, ComfortGlide Drypad, Convertors, DISPOSABLE BEDDING, Eclipse Surgical Drape, Extrasorb and more

Devices it lists

Device	Product code	Class	Role	Source
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic	JOP	2	Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US	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
June 9, 1999	K990912	MTP EXTRACTION BAG	GCJ	Substantially Equivalent	Mtp Medical Technical Promotion GmbH	accessdata.fda.gov
February 23, 1995	K921695	ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS	ITX	Substantially Equivalent	Parker Laboratories, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 9, 1999. 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.