Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043047582

FEI Number

3043047582

Entity Name

OY PRIMO FINLAND AB

City/State/Country

Vaasa Pohjanmaa, FI

Establishment Address

Tarhaajantie 2, Vaasa Pohjanmaa FI-65380, FI

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Oy Primo Finland Ab (Owner Number: 10094739)

Owner / Operator Contact Address

Tarhaajantie 2, Vaasa, FI-12 FI-65380, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ucast Procast Woodcast

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2026-06-05

Official Correspondent

Katariina Koski

US Agent Details

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

Related Public Records

Same Entity

Oy Primo Finland 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 3043047582. Last updated year: 2026. Please use registration number 3043047582 when referencing this establishment in official correspondence.