Microtek Medical B.V.

FDA Device Registration & Listing · Zutphen Gelderland, NL · Registration 3006116468

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006116468
FEI Number
3006116468
Entity Name
Microtek Medical B.V.
City/State/Country
Zutphen Gelderland, NL
Establishment Address
HEKKEHORST 24, Zutphen Gelderland 7207 BN, NL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medline Industries, LP (Owner Number: 1417592)
Owner / Operator Contact Address
Three Lakes Drive, Northfield, IL 60093, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Parker Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Rolled Probe Cover Phillips Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-10-31
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-08-25
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2024-10-30
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2014-10-20

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007128716 Medline Industries, LP Norristown, PA, US
3036706541 EXCELSIOR MEDICAL LLC Tinton Falls, NJ, US
3016073670 Medline Logistics Japan G.K. Nishihocho, Aisai-shi Aichi, JP
3006581049 MICROTEK MEDICAL MALTA LIMITED Mosta, MT
3010389834 Microtek Medical B.V. Varsseveld VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

Similar Registrations

Registration Number Establishment Name Location
3008515880 EZONO AG Jena Thuringia, DE
3029744051 LYSIS HEALTHCARE GMBH Graz Steiermark, AT
3014574557 ADECHOTECH NAVEIL Loir-et-Cher, FR
3012081348 THE SENTINEL IMAGING GROUP, INC Clarks Summit, PA, US
3025786376 ACO HEALTHCARE CO., LTD. Taoyuan City, TW
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006116468. Last updated year: 2026. Please use registration number 3006116468 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.