Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003766921

FEI Number

3003766921

Entity Name

APOTEK PRODUKTION & LABORATORIER AB

City/State/Country

Umea Vasterbotten, SE

Establishment Address

Formvagen 5B, Box 3076, Umea Vasterbotten SE -903 03, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Apotek Produktion & Laboratorier AB (Owner Number: 10049199)

Owner / Operator Contact Address

Formvagen 5B, Box 3076, Umea, SE-AC SE-90303, SE

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
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2026-02-20
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Unknown	Class 3	N/A	2015-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

Jane Campbell Business: J & D Campbell Associates, Inc. Email: jdcainc.sc@gmail.com Phone: (843) 3143670

Related Public Records

Same Entity

Apotek Produktion & Laboratorier AB

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
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003766921. Last updated year: 2026. Please use registration number 3003766921 when referencing this establishment in official correspondence.