Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017299606

FEI Number

3017299606

Entity Name

CYTODELICS AB

City/State/Country

Sodertalje Stockholm, SE

Establishment Address

Forskargatan 20J, Sodertalje Stockholm 151 36, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cytodelics AB (Owner Number: 10088741)

Owner / Operator Contact Address

Forskargatan 20J, Sodertalje, SE-AB 151 36, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cryogenic tube pre-filled with the Cytodelics STABILISER (1.5 ml), cat#hWBCS001-T015 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.3 ml), cat#hWBCS001-T003 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.2 ml), cat#hWBCS001-T002 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.7 ml), cat#hWBCS001-T007 Whole blood cell STABILISER Cytodelics STABILISER Cryogenic tube pre-filled with the Cytodelics STABILISER (0.5 ml), cat#hWBCS001-T005 Cryogenic tube pre-filled with the Cytodelics STABILISER (1 ml), cat#hWBCS001-T010 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.9 ml), cat#hWBCS001-T009 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.1 ml), cat#hWBCS001-T001 Cryogenic tube pre-filled with the Cytodelics STABILISER (2 ml), cat#hWBCS001-T020 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.8 ml), cat#hWBCS001-T008 Cryogenic tube pre-filled with the Cytodelics STABILISER (0.5 ml), cat#hWBCS001-T006

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-10-10

Official Correspondent

Jaromir Mikes

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Cytodelics 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 3017299606. Last updated year: 2026. Please use registration number 3017299606 when referencing this establishment in official correspondence.