Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010958377

FEI Number

3010958377

Entity Name

Biometrix sro

City/State/Country

Samorin Bratislavsky, SK

Establishment Address

Vicenzy 16, Samorin Bratislavsky 93101, SK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

QMD (Owner Number: 8030107)

Owner / Operator Contact Address

DEGANIA BET, Degania Bet, IL-Z 1513000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2015-02-04

Official Correspondent

Tal Gafni

US Agent Details

Angie Doe Email: adoe@qmd.net Phone: (262) 8331571

Related Public Records

Same Entity

QMD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016099072	Shomrat Molds Ltd	Hatzor Haglilit Northern, IL
8030115	BIOMETRIX LTD.	JERUSALEM, IL
3005483737	DEGANIA MEDICAL DEVICES PVT. LTD.	GURGAON Haryana, IN
8030107	DEGANIA SILICONE, LTD.	DEGANIA BET Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010958377. Last updated year: 2026. Please use registration number 3010958377 when referencing this establishment in official correspondence.