Svar Life Science AB

FDA Device Registration & Listing · MALMO Skane, SE · Registration 9616003

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616003
FEI Number
3007610287
Entity Name
Svar Life Science AB
City/State/Country
MALMO Skane, SE
Establishment Address
Lundavagen 151, MALMO Skane SE-212 24, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Svar Life Science AB (Owner Number: 9030111)
Owner / Operator Contact Address
Lundavagen 151, --, MALMO, SE-M SE-212 24, SE
Initial Importer Flag
N
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
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2007-12-10
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2007-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Consulting LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Svar Life Science AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2007 N/A 2
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616003. Last updated year: 2026. Please use registration number 9616003 when referencing this establishment in official correspondence.
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