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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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Specimen Collection Kit — 1 UDI-DI variant, IVDR (Agendia N.V)

MD Atlas
Agendia N.V

Data from EUDAMED, last updated May 30, 2026

Specimen Collection Kit

0850024841ESM107QL

1 UDI-DI variant

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: Agendia N.V

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 0850024841ESM107QL
Device name: Specimen Collection Kit
Device model: Agendia ES FFPE W/Slides
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 13, 2022

Manufacturer & authorised representative

Manufacturer

Name: Agendia N.V
SRN: NL-MF-000011684
Country: Netherlands
Email: melissa.chavis@agendia.com
Phone: +18587223685

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01G0HVJXRQGXK6SWVCT0DEZWX6

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

Specimen Collection Kit00850024841260