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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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InstaSep — 3 UDI-DI variants, IVDR (SampleFacts AB)

MD Atlas
SampleFacts AB

Data from EUDAMED, last updated May 31, 2026

InstaSep

735017860InstaSepNC

3 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: SampleFacts AB

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 735017860InstaSepNC
Device name: InstaSep
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 18, 2026

Manufacturer & authorised representative

Manufacturer

Name: SampleFacts AB
SRN: SE-MF-000048513
Country: Sweden
Email: maryam.poorafshar@samplefacts.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01KRXMFAQE5SP5JSWFZG96BD9W

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

SampleFacts InstaSep 3007350178600018
SampleFacts InstaSep 4007350178600025
SampleFacts InstaSep 5007350178600032