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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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02.08.2026 22:01

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52 device results listed.

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CK (NAC & MB) Control

HBC08

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101414
Basic UDI-DI: B-05404035101414
Reference: HBC08
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

00817238010042

91474

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Cliniqa Corporation
Manufacturer SRN: US-MF-000023908
UDI-DI: 00817238010042
Basic UDI-DI: B-00817238010042
Reference: 91474
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Austria
Authorised representative: CEpartner4U
Last updated: 01.08.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)

ALDOLASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273200096
Basic UDI-DI: 50552732BALSCON005DZ
Reference: AD5001
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

CK-MB CONTROL

CKMB-0900

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700818908
Basic UDI-DI: 37017008CKMB056K
Reference: CKMB-0900
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:50

Manufacturer products View details

CK-NAC / CK-MB CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673022624
Basic UDI-DI: B-08431673022624
Reference: 1002262
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:15

Manufacturer products View details

CK-NAC / CK-MB CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673022600
Basic UDI-DI: B-08431673022600
Reference: 1002260
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:15

Manufacturer products View details

D-6297S

Enzyme Multical Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6297S
Basic UDI-DI: B-6297S
Reference: /
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-13A3

Enzyme compound quality control products

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-13A3
Basic UDI-DI: B-6-13A3
Reference: "REF: USCA00000707, USCA00000708, USCA00000709, USCA00000710"
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB CONTROL

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700818915
Basic UDI-DI: 37017008CKMB056K
Reference: CKMB-1030
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 02:21

Manufacturer products View details

D-Q90100BFM

F-Q1, F-Q2, F-Q4

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-Q90100BFM
Basic UDI-DI: B-Q90100BFM
Reference: /
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-Q90100AFK

F-8Q1, F-8Q2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-Q90100AFK
Basic UDI-DI: B-Q90100AFK
Reference: /
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01982189L

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01982189L
Basic UDI-DI: B-ECH01982189L
Reference: ECH0198218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01972189D

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01972189D
Basic UDI-DI: B-ECH01972189D
Reference: ECH0197218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019621896

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019621896
Basic UDI-DI: B-ECH019621896
Reference: ECH0196218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01952188X

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01952188X
Basic UDI-DI: B-ECH01952188X
Reference: ECH0195218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01942188Q

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01942188Q
Basic UDI-DI: B-ECH01942188Q
Reference: ECH0194218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01932188H

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01932188H
Basic UDI-DI: B-ECH01932188H
Reference: ECH0193218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019320588

α-L-Fucosidase (AFU) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019320588
Basic UDI-DI: B-ECH019320588
Reference: ECH0193205
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01922188A

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01922188A
Basic UDI-DI: B-ECH01922188A
Reference: ECH0192218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01922057Z

α-L-Fucosidase (AFU) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01922057Z
Basic UDI-DI: B-ECH01922057Z
Reference: ECH0192205
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details