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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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NF-light ELISA — 1 UDI-DI variant, IVDD (UmanDiagnostics 5566982418)

MD Atlas
UmanDiagnostics 5566982418

Data from EUDAMED, last updated May 30, 2026

NF-light ELISA

B-SE-MF-0000314075B

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: UmanDiagnostics 5566982418

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Device characteristics

Professional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: B-SE-MF-0000314075B
Device name: NF-light ELISA
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: Dec 8, 2022

Manufacturer & authorised representative

Manufacturer

Name: UmanDiagnostics 5566982418
SRN: SE-MF-000031407
Country: Sweden
Email: mstigbrand@quanterix.com
Phone: +46703371480

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01GKGYGSBTTP860P2V4NX7Z136

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

NF-light ELISAD-SE-MF-0000314075B