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235 device results listed.

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MutaPLEX® Babesia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005570
Basic UDI-DI: B-04050598005570
Reference: KG192496
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:44

Manufacturer products View details

MutaPLEX® Babesia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005563
Basic UDI-DI: B-04050598005563
Reference: KG192432
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:44

Manufacturer products View details

MutaPLEX® Rickettsia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005556
Basic UDI-DI: B-04050598005556
Reference: KG192332
EMDN: W0105011605
EMDN description: RICKETTSIA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:44

Manufacturer products View details

MutaPLEX® Rickettsia, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005549
Basic UDI-DI: B-04050598005549
Reference: KG192396
EMDN: W0105011605
EMDN description: RICKETTSIA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:44

Manufacturer products View details

MutaPLEX® Blastocystis, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598005532
Basic UDI-DI: B-04050598005532
Reference: KG191896
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:44

Manufacturer products View details

MutaPLEX® Bordetella pertussis/parapertussis, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003484
Basic UDI-DI: B-04050598003484
Reference: KG190932
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:43

Manufacturer products View details

04049095160325

RIDA®GENE Bordetella

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095160325
Basic UDI-DI: B-04049095160325
Reference: PG2505
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

micro-IDent®plus11 VER 1.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002917
Basic UDI-DI: B-04049055002917
Reference: 23396
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:04

Manufacturer products View details

micro-IDent® VER 2.0

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000531
Basic UDI-DI: B-04049055000531
Reference: 23296
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:03

Manufacturer products View details

Bacillus Anthracis Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807170093PR
Basic UDI-DI: B-000012807170093PR
Reference: HWTS-OT018
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Leptospira Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930658
Basic UDI-DI: 89080153043B249NR
Reference: 3B249/C
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

5.182.XXX.YY.ZZZ

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003122
Basic UDI-DI: 84295775182XE
Reference: 5.182.096.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003139
Basic UDI-DI: 84295775182XE
Reference: 5.182.048.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

Aptima BV Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512023
Basic UDI-DI: 54200455DIAGAPTBVRB
Reference: PRD-05186
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Lyophilized rabbit plasma

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026584078
Basic UDI-DI: 357302BUDI000489U8
Reference: 540603
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 03:35

Manufacturer products View details

04049095210174

RIDA®UNITY Bordetella

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210174
Basic UDI-DI: 4049095UN25050000R6
Reference: UN2505
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

BIOSYNEX AMPLIQUICK Bordetella

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593685
Basic UDI-DI: 353267F00133P7Y
Reference: 3150068_SEC01
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

BIOSYNEX AMPLIQUICK Leptospira

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678593197
Basic UDI-DI: 353267F00057P8F
Reference: 3150064
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

VIASURE

VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440258704
Basic UDI-DI: 84354402MDXRESISTC_BMGMHP
Reference: 444224
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:31

Manufacturer products View details

EasyNAT BP Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240176
Basic UDI-DI: 697349224U2020092C000GU
Reference: U20209
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details