Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038280303

FEI Number

3038280303

Entity Name

X-MED AB

City/State/Country

Vasteras Vastmanland, SE

Establishment Address

Nyckelovagen 18, Vasteras Vastmanland SE-72592, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

X-Med AB (Owner Number: 10093407)

Owner / Operator Contact Address

Nyckelovagen 18, Vasteras, SE-NOTA SE-72592, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Align Halo Gravity Traction

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2025-05-12

Official Correspondent

Rune Wallner

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

X-Med AB

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2087341	GIBBONS HEALTH PRODUCTS, INC.	STUDIO CITY, CA, US
3004012851	IHN, INC	Okemos, MI, US
3023187489	MAGNATE HEALTH TECH. CO., LTD	TAIPEI CITY, TW
3014680784	Domico Med-Device, LLC	Fenton, MI, US
2936485	STRYKER ENDOSCOPY	SAN JOSE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038280303. Last updated year: 2026. Please use registration number 3038280303 when referencing this establishment in official correspondence.