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Serum Control Bi-Level (I+II)

Vitamins A and E in serum/plasma

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317505736
Basic UDI-DI: 4250317340004H
Reference: 0032
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 02:00

Manufacturer products View details

Galaktose peptonvand

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106802397
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 80239
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 01:52

Manufacturer products View details

MagaBio plus General Genomic DNA Purification Kit Ⅱ

BSC74S1B, BSC74M1B, BSC74M1S, BSC74N1E, BSC74T1S, BSC74S1S, BSC74M1E, BSC74L1E, BSC74T1E, BSC74S1E, BSC74T1C, BSC74S1C, BSC74M1E-T, BSC74L1E-T, BSC74T1C-C, BSC74S1C-C, BSC74S1P-A

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221779
Basic UDI-DI: 697384322BSC74J2
Reference: BSC74N1E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.09.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio FFPE Tissue Genomic DNA Purification Kit

BSC31S1, BSC31M1, BSC31M1S, BSC31N1E, BSC31T1S, BSC31S1S, BSC31M1E, BSC31L1E, BSC31T1E, BSC31S1E, BSC31T1C, BSC31S1C, BSC31M1E-T, BSC31L1E-T, BSC31T1C-C, BSC31S1C-C, BSC31S1P-A

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221694
Basic UDI-DI: 697384322BSC31HG
Reference: BSC31N1E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.09.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer A til dermatophyte PCR kit

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106801925
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 80192
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 01:39

Manufacturer products View details

LC-MS/MS Reagent Kit MassTox® Immunosuppressants in whole blood

MassTox® Immunosuppressants in whole blood

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317520258
Basic UDI-DI: 4250317930006C
Reference: 93000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 01:29

Manufacturer products View details

VIASURE Clostridium difficile toxB Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440203766
Basic UDI-DI: 84354402_MDXGASTROB_CTBQQ
Reference: VS-CTB106L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:25

Manufacturer products View details

Schwörmagar

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106624111
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 62411
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 01:23

Manufacturer products View details

Whole Blood Control Bi-Level (I+II)

Vitamin B6 in Plasma/Serum/Whole Blood

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317503350
Basic UDI-DI: 4250317310003U
Reference: 0022
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 01:22

Manufacturer products View details

VIASURE Entamoeba dispar Real Time PCR Detection Kit

IVD Class BNot specifiedOn the market

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440203414
Basic UDI-DI: 84354402_MDXGASTROB_ETDR6
Reference: VS-ETD106L
EMDN: W0105050399
EMDN description: OTHER PARASITOLOGY - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:14

Manufacturer products View details

VIASURE Clostridium difficile Real Time PCR Detection Kit

IVD Class BNot specifiedOn the market

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202998
Basic UDI-DI: 84354402_MDXGASTROB_CDSQA
Reference: VS-CDS106L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:14

Manufacturer products View details

VIASURE Sapovirus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202875
Basic UDI-DI: 84354402_MDXGASTROB_SAVSP
Reference: VS-SAV106L
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:14

Manufacturer products View details

VIASURE Astrovirus Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202813
Basic UDI-DI: 84354402_MDXGASTROB_ATVRN
Reference: VS-ATV106L
EMDN: W0105040530
EMDN description: ASTROVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 01:14

Manufacturer products View details

Specific Protein Control

Analyzer(automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925051468
Basic UDI-DI: 697492505000008TJ
Reference: CAB0101
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

BHI m. 15 % glycerol

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106624012
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 62401
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 01:09

Manufacturer products View details

PPLO FB u. antibiotika

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106623961
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 57695
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 01:00

Manufacturer products View details

Middlebrook 7H10 skråagar m. 12 cm slope

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106501856
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 50185
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 00:54

Manufacturer products View details

Tuning Mix

MassTox® Immunosuppressants in whole blood

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317520227
Basic UDI-DI: 4250317930006C
Reference: 93015
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 00:50

Manufacturer products View details

09120036863835

Technoview Edoxaban CON L

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036863835
Basic UDI-DI: B-09120036863835
Reference: 5090251
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Austria
Authorised representative: -
Last updated: 23.09.2026 00:48

Manufacturer products View details

09120036863828

Technoview Edoxaban CAL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036863828
Basic UDI-DI: B-09120036863828
Reference: 5090250
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Austria
Authorised representative: -
Last updated: 23.09.2026 00:47

Manufacturer products View details