Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010646683

FEI Number

3010646683

Entity Name

HARNOSANDS PLASTINDUSTRI AB

City/State/Country

Harnosand Vasternorrland, SE

Establishment Address

Verkstadsvagen 17, Harnosand Vasternorrland 87154, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Harnosands Plastindustri AB (Owner Number: 10075967)

Owner / Operator Contact Address

Verkstadsvagen 17, Harnosand, SE-Y 87154, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AFO Leaf Spring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-07-02

Official Correspondent

Katla Axelsdottir

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

Harnosands Plastindustri AB

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010646683. Last updated year: 2026. Please use registration number 3010646683 when referencing this establishment in official correspondence.