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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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Cardiac Medication Reagent Set — 1 UDI-DI variant, IVDD

MD Atlas
Diagnotix B.V.

Data from EUDAMED, last updated May 30, 2026

Cardiac Medication Reagent Set

B-4160PCARKW

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: Diagnotix B.V.

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Device characteristics

ReagentProfessional testingHuman tissues / cells

Identity & classification

Basic UDI-DI: B-4160PCARKW
Device name: Cardiac Medication Reagent Set
Device model: 4160 P CAR
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: Jun 9, 2022

Manufacturer & authorised representative

Manufacturer

Name: Diagnotix B.V.
SRN: NL-MF-000000236
Country: Netherlands
Email: info@diagnotix.com
Phone: +31 596 201062

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01G544M4SCVTNGEY6Q3DBN47BJ

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

4160 P CARD-4160PCARKW