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γ-GT LIQ R1:8x50 R2:4x20ml (HIT)

γ-GT LIQ R1:8x50 R2:4x20ml (HIT)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003191612
Basic UDI-DI: B-05213003191612
Reference: 001539
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

LDH SL R1:2x20ml,R2:1x10ml(HIT)

LDH SL R1:2x20ml,R2:1x10ml(HIT)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003191513
Basic UDI-DI: B-05213003191513
Reference: 001521
EMDN: W01010120
EMDN description: LACTATE DEHYDROGENASE P ( LDH - P --> L )
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

LDH SL R1:6x20ml,R2:2x15ml(HIT)

LDH SL R1:6x20ml,R2:2x15ml(HIT)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003191506
Basic UDI-DI: B-05213003191506
Reference: 001520
EMDN: W01010120
EMDN description: LACTATE DEHYDROGENASE P ( LDH - P --> L )
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

ΑΛΚ.ΦΩΣΦΑΤΑΣΗ IFCC R1:4x50, R2 2x20 ml (HIT)

ΑΛΚ.ΦΩΣΦΑΤΑΣΗ IFCC R1:4x50, R2 2x20 ml (HIT)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003191490
Basic UDI-DI: B-05213003191490
Reference: 001518
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

ΑΛΚ.ΦΩΣΦΑΤΑΣΗ IFCC R1:8x50, R2 4x20 ml (ΗΙΤ)

ΑΛΚ.ΦΩΣΦΑΤΑΣΗ IFCC R1:8x50, R2 4x20 ml (ΗΙΤ)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003191483
Basic UDI-DI: B-05213003191483
Reference: 001517
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

IDS ACE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693722
Basic UDI-DI: B-05060169693722
Reference: IS-5900
EMDN: W01010109
EMDN description: ANGIOTENSIN CONVERTING ENZYME (CC)
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK CK-MB SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211681
Basic UDI-DI: B-04560189211681
Reference: 0020569
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

AIA-PACK CK-MB CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189211674
Basic UDI-DI: B-04560189211674
Reference: 0020369
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

PP229AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627012173
Basic UDI-DI: B-00847627012173
Reference: PP229AA
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

CP229C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007957
Basic UDI-DI: B-00847627007957
Reference: CP229C
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

CP229B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007940
Basic UDI-DI: B-00847627007940
Reference: CP229B
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

CP229A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007933
Basic UDI-DI: B-00847627007933
Reference: CP229A
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Finland
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656825
Basic UDI-DI: B-00810173656825
Reference: 1CKMBB02
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656818
Basic UDI-DI: B-00810173656818
Reference: 1CKMBB01
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760283
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760290
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

General

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760245
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

AA05-01-24S

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760214
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)

105-009264-00、105-002254-00、105-002255-00、105-002308-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032269
Basic UDI-DI: 69449040004JG6PD*******C3
Reference: 105-002254-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cholinesterase (CHE) Kit (DGKC Method)

105-002162-00、105-002163-00、105-002164-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037431
Basic UDI-DI: 69449040004ECHE********SY
Reference: 105-002162-00
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details