Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015542780

FEI Number

3015542780

Entity Name

CAPITAINER AB

City/State/Country

Solna Stockholm, SE

Establishment Address

Solna Torg 19, Solna Stockholm 171 45, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Capitainer AB (Owner Number: 10060888)

Owner / Operator Contact Address

Solna torg 19, Solna, SE-AB 171 45, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CapitainerSEP10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2024-12-19

Official Correspondent

Par Lido

US Agent Details

Carissa Jones Email: carissa.jones@capitainer.com Phone: (336) 6559096

Related Public Records

Same Entity

Capitainer AB

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

View Entity Profile →

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3013096769	Genolution Inc	Inchecon Incheon, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015542780. Last updated year: 2026. Please use registration number 3015542780 when referencing this establishment in official correspondence.