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Manufacturer products Authorised representative products Authorised representative actors View details

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229602
Basic UDI-DI: B-06942202229602
Reference: 3003153
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229619
Basic UDI-DI: B-06942202229619
Reference: 3003159
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test

1156-VDC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432172
Basic UDI-DI: B-00850082432172
Reference: 1156-VDC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 06:57

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GLUCO TEST Plus Kontrolllösung hoch

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingReagentSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04251575910478
Basic UDI-DI: B-04251575910478
Reference: TD-4912
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCO TEST DUO Kontrolllösung hoch

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04251575910454
Basic UDI-DI: B-04251575910454
Reference: TD-4908
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819087
Basic UDI-DI: 6438153BU00050BG
Reference: 981908
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

Lipotrol

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816536
Basic UDI-DI: 6438153BU00141BL
Reference: 981653
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

CK-MB Control High

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153812552
Basic UDI-DI: 6438153BU00051BJ
Reference: 981255
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217926
Basic UDI-DI: 50552732BLBCNL30345F
Reference: BR10391
EMDN: W0101050203
EMDN description: BILIRUBIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 04.08.2026 21:34

ADA, KIT DE CONTROL

ADENOSINA DESAMINASA CONTROLES

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008863
Basic UDI-DI: B-18430155008863
Reference: 993240
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:47

FUJI DRI-CHEM ELECTROLYTE CONTROL QE

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 14902520282672
Basic UDI-DI: B-14902520282672
Reference: 14902520282672
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 04.08.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

Manufacturer products Authorised representative products Authorised representative actors View details

Level2: 3×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247255
Basic UDI-DI: B-06942202247255
Reference: 3003171
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Level2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247248
Basic UDI-DI: B-06942202247248
Reference: 3003169
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Level1: 3×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247231
Basic UDI-DI: B-06942202247231
Reference: 3003165
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Level1: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247224
Basic UDI-DI: B-06942202247224
Reference: 3003163
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Level2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247217
Basic UDI-DI: B-06942202247217
Reference: 3003157
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16