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EUDAMED Device Search

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

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D-697603130CSTIZK01AR77C

CSTIZK01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CSTIZK01AR77C
Basic UDI-DI: B-697603130CSTIZK01AR77C
Reference: CSTIZK01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CRTI701AWBSW

CRTI701A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CRTI701AWBSW
Basic UDI-DI: B-697603130CRTI701AWBSW
Reference: CRTI701A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CRTI601AW4RP

CRTI601A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CRTI601AW4RP
Basic UDI-DI: B-697603130CRTI601AW4RP
Reference: CRTI601A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CGCT01AD5VC

CGCT01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CGCT01AD5VC
Basic UDI-DI: B-697603130CGCT01AD5VC
Reference: CGCT01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130ASTD1301S3HX

ASTD1301

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130ASTD1301S3HX
Basic UDI-DI: B-697603130ASTD1301S3HX
Reference: ASTD1301
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130APA019C8E

APA01,APA01D

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130APA019C8E
Basic UDI-DI: B-697603130APA019C8E
Reference: APA01,APA01D
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130AFR019TB9

AFR01,AFR01D

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130AFR019TB9
Basic UDI-DI: B-697603130AFR019TB9
Reference: AFR01,AFR01D
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AFR01QCQZ

APA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AFR01QCQZ
Basic UDI-DI: B-69509960AFR01QCQZ
Reference: APA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

RT-qPCR Assay

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915CD006LLAP
Basic UDI-DI: B-5713915CD006LLAP
Reference: 8200, 8201
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

RT-qPCR Assay

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915CD005LJAE
Basic UDI-DI: B-5713915CD005LJAE
Reference: 8177, 8180
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

Xpert® Xpress CoV-2/Flu/RSV plus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008000
Basic UDI-DI: B-07332940008000
Reference: XP3COV2/FLU/RSV-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007058
Basic UDI-DI: B-07332940007058
Reference: GXCT/NGX-CE-120
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007041
Basic UDI-DI: B-07332940007041
Reference: GXCT/NGX-CE-10
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001919
Basic UDI-DI: B-07332940001919
Reference: GXCT/NG-CE-120
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert® CT/NG

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000073
Basic UDI-DI: B-07332940000073
Reference: GXCT/NG-CE-10
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

VIASURE H. influenzae, N. meningitidis & S. pneumoniae Real Time PCR Detection Kit

VIASURE H. influenzae, N. meningitidis & S. pneumoniae Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207917
Basic UDI-DI: 84354402_MDXMENIN_HNSZ7
Reference: VS-HNS106L
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

Panther Fusion GI Expanded Bacterial Assay

Panther Fusion GI Expanded Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517509
Basic UDI-DI: 54200455DIAGPFGIEXPBACUK
Reference: PRD-07121
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion GI Bacterial Assay

Panther Fusion GI Bacterial Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517486
Basic UDI-DI: 54200455DIAGPFGIBACUY
Reference: PRD-07113
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

QIAstat-Dx Gastrointestinal Panel 2

QIAstat-Dx Gastrointestinal Panel 2

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228045519
Basic UDI-DI: 4053228RGI2QST000000001RK
Reference: 691413
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 08:31

Manufacturer products View details

ALINITY M STI

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999051218
Basic UDI-DI: 0884999AMN0040W8
Reference: 09N17-092
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details