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06977805760245

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

06977805760214

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

α-L-Fucosidase Kit (CNPF Method)

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904034959
Basic UDI-DI: 694490400043AFU********F3
Reference: 105-003123-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Adenosine Deaminase Kit (Enzymatic Colorimetric Method)

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011563
Basic UDI-DI: 694490400043ADA********WS
Reference: 105-026284-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Pankreatische Amylase ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598164109
Basic UDI-DI: B-04050598164109
Reference: K 6410
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598168404
Basic UDI-DI: B-04050598168404
Reference: K 6840
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

Diaminooxidase (DAO) (3H-Nuclid) REA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598182202
Basic UDI-DI: B-04050598182202
Reference: K 8220
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® DAO ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598185005
Basic UDI-DI: B-04050598185005
Reference: K 8500
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® Diaminooxidase (DAO) (1-Punkt-Kalibrierung) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598185104
Basic UDI-DI: B-04050598185104
Reference: K 8510
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

NITROCEFIN + RECONSTITUTION FLUID

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384011872
Basic UDI-DI: 5032384NitrocefinRecFldZF
Reference: SR0112C
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

BROAD SPECTRUM BETA-LACTAMASE MIXTURE

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384011889
Basic UDI-DI: 5032384BrdSpecBetaLact6Q
Reference: SR0113E
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

PENASE

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013944
Basic UDI-DI: 5032384Penase1Vial8X
Reference: SR0129B
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

EpiScreen Plus Reagent 1

EPI_PLUS

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001620
Basic UDI-DI: 5411967EPIP1VD
Reference: EPI_PLUS_1
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

Manufacturer products View details

EpiScreen Plus

EPI_PLUS

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967000012
Basic UDI-DI: 5411967EPIP1VD
Reference: EPI_PLUS
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:51

Manufacturer products View details

06977805760252

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

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760252
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760269

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

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760269
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Pyridoxal Phosphate Liquid

60106

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590170349
Basic UDI-DI: 15099590160106R5
Reference: 60106
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Enzymatic Creatinine

OSR61204

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590011918
Basic UDI-DI: 150995902OSR61204TC
Reference: OSR61204
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:29

Manufacturer products View details

α-AMYLASE

OSR6106

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010058
Basic UDI-DI: 150995901OSR6106LX
Reference: OSR6106
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details