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ImmunoIVD AB

Active in EUDAMED

Swedenfrom SRN EUDAMED SRN SE-MF-000034517

Devices
8
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What ImmunoIVD AB makes

ImmunoIVD AB manufactures in vitro diagnostic (IVD) screening kits designed for detecting genetic markers associated with specific congenital disorders. Their products include assays for T-cell receptor excision circles (TREC), KREC, and spinal muscular atrophy type 1 (SMN1), used primarily in newborn screening programs.

These diagnostic tools are classified under EU IVD General (Class C) and are registered in the EU’s eudamed database. The company is based in Sweden and adheres to EU regulatory requirements for in vitro diagnostic medical devices.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

Company details

EUDAMED SRN
SE-MF-000034517
EU VAT number
SE559018073201
EUDAMED status
Active
EUDAMED registered name
ImmunoIVD AB
Registered address
1140, Box, 13126, Nacka Strand, Sweden
Phone
+46 840 88 98 00
PRRC contact
Richard Herrmann(public in EUDAMED)

From the company website

Read 18 Sep 2026

Reliable and innovative CE marked in vitro diagnostic assays for newborn screening for SCID, SMA, and XLA.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does ImmunoIVD AB have in the registry?

The registry currently lists 8 devices for ImmunoIVD AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list ImmunoIVD AB's devices?

Among its 8 most recently registered devices, ImmunoIVD AB has devices listed in EUDAMED (8 devices).

What risk classes do ImmunoIVD AB's devices fall under?

Among its 8 most recently registered devices, the classes recorded for ImmunoIVD AB's devices are IVDR Class C and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from ImmunoIVD AB in the registry?

The most recently registered devices listed for ImmunoIVD AB include SPOT-it TREC, KREC & SMN1 Screening Kit, SPOT-it TREC & KREC Screening Kit, SPOT-it TREC & SMN1 Screening Kit and SPOT-it TREC Screening Kit.

Generated automatically from registry data and not verified by a human reviewer.