Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004030908

FEI Number

3004030908

Entity Name

AB ULAX

City/State/Country

MOTALA Ostergotland, SE

Establishment Address

MERKURIUSGATAN 8, MOTALA Ostergotland 591 32, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AB ULAX (Owner Number: 9070340)

Owner / Operator Contact Address

MERKURIUSGATAN 8, --, MOTALA, SE-NOTA 591 32, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

6000 HME Trach 6000 3310 HME Mini Flex TFH104 6000 HME Trach 3300 HME Flex 1001 HME Small 1002 HME Medium 1003 HME Large Foam Filter MP05750 HME HumidStar Trach Plus MP05845 HME HumidStar 2 Plus 950 HME Neo Luer-Lock 6010 HME Trach Oxygen 6mm 910 HME Neo 910 MP25841 CH Care HME Trach 2200 Flexsoft FOAM FILTER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2009-10-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2005-02-15

Official Correspondent

CHRISTER JOSEPHSON

US Agent Details

Richard B. Kennedy Business: Trinity Medical Devices Inc. Email: rkennedy@trinitymdi.com Phone: (973) 2650766

Related Public Records

Same Entity

AB ULAX

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004030908. Last updated year: 2026. Please use registration number 3004030908 when referencing this establishment in official correspondence.