- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer SRN
- ES-MF-000002193
- UDI-DI
- 08435440260561
- Basic UDI-DI
- 84354402_MDXRESIST_CAUL3
- Reference
- VS-CAU113HE
- EMDN
- W0105060404
- EMDN description
- CANDIDA AURIS - NA REAGENTS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 06.07.2026 22:54
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
19.09.2026 19:15
Sync status
Successful
Device
3108040
Actor
47631
Certificate
3283
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer SRN
- ES-MF-000002193
- UDI-DI
- 08435440260578
- Basic UDI-DI
- 84354402_MDXRESIST_CAUL3
- Reference
- VS-CAU196TE
- EMDN
- W0105060404
- EMDN description
- CANDIDA AURIS - NA REAGENTS
- First on market country
- -
- Authorised representative
- -
- Last updated
- 06.07.2026 22:54
Pneumocystis jirovecii Real Time PCR Kit
Pneumocystis jirovecii Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042229169
- Basic UDI-DI
- B-06971042229169
- Reference
- QD-0082-02
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 12:03
Fungus Real Time PCR Kit
Fungus Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042228995
- Basic UDI-DI
- B-06971042228995
- Reference
- FD-0330-02
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 12:03
Candida Albicans Real Time PCR Kit
Candida Albicans Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042228988
- Basic UDI-DI
- B-06971042228988
- Reference
- FD-0329-02
- EMDN
- W0105060402
- EMDN description
- CANDIDA ALBICANS - NA REAGENTS
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 12:03
Cryptococcus Neoformans Real Time PCR Kit
Cryptococcus Neoformans Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042225161
- Basic UDI-DI
- B-06971042225161
- Reference
- FD-0328-02
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 11:56
IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Vircell, S.L
- Manufacturer SRN
- ES-MF-000004099
- UDI-DI
- 08436610290180
- Basic UDI-DI
- 843661029RTPCR027018Y
- Reference
- RTPCR027-LP
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 03.07.2026 14:57
03770041419099
60318
IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- ADEMTECH
- Manufacturer SRN
- FR-MF-000048678
- UDI-DI
- 03770041419099
- Basic UDI-DI
- 377004141960318CK
- Reference
- 60318
- EMDN
- W0105060405
- EMDN description
- PNEUMOCYSTIS - NA REAGENTS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 01.07.2026 16:16
03770041419044
60307
IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
- Manufacturer
- ADEMTECH
- Manufacturer SRN
- FR-MF-000048678
- UDI-DI
- 03770041419044
- Basic UDI-DI
- 377004141960307CE
- Reference
- 60307
- EMDN
- W0105060405
- EMDN description
- PNEUMOCYSTIS - NA REAGENTS
- First on market country
- France
- Authorised representative
- -
- Last updated
- 01.07.2026 16:16
06970895475655
Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
IVD generalIVDDOn the marketProfessional testingReagent
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- Manufacturer SRN
- CN-MF-000001539
- UDI-DI
- 06970895475655
- Basic UDI-DI
- B-06970895475655
- Reference
- B70201T2048
- EMDN
- W0105060404
- EMDN description
- CANDIDA AURIS - NA REAGENTS
- First on market country
- Greece
- Authorised representative
- Medunion S.L.
- Last updated
- 30.06.2026 09:55
06970895475648
Candida Auris Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
IVD generalIVDDOn the marketProfessional testingReagent
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- Manufacturer SRN
- CN-MF-000001539
- UDI-DI
- 06970895475648
- Basic UDI-DI
- B-06970895475648
- Reference
- B701T050B0C1
- EMDN
- W0105060404
- EMDN description
- CANDIDA AURIS - NA REAGENTS
- First on market country
- Greece
- Authorised representative
- Medunion S.L.
- Last updated
- 30.06.2026 09:55
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081137
- Basic UDI-DI
- B-06970514081137
- Reference
- FCPCR-50
- EMDN
- W0105060403
- EMDN description
- CRYPTOCOCCUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:08
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081120
- Basic UDI-DI
- B-06970514081120
- Reference
- FCPCR-25
- EMDN
- W0105060403
- EMDN description
- CRYPTOCOCCUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081113
- Basic UDI-DI
- B-06970514081113
- Reference
- FTMPCR-50
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081106
- Basic UDI-DI
- B-06970514081106
- Reference
- FTMPCR-25
- EMDN
- W0105060499
- EMDN description
- MYCOLOGY NA REAGENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081076
- Basic UDI-DI
- B-06970514081076
- Reference
- FCUPCR-50
- EMDN
- W0105060402
- EMDN description
- CANDIDA ALBICANS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081069
- Basic UDI-DI
- B-06970514081069
- Reference
- FCUPCR-25
- EMDN
- W0105060402
- EMDN description
- CANDIDA ALBICANS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
06970514081052
Candida Molecular Detection Kit (Real-time PCR)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081052
- Basic UDI-DI
- B-06970514081052
- Reference
- FCAPCR-50
- EMDN
- W0105060402
- EMDN description
- CANDIDA ALBICANS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
06970514081045
Candida Molecular Detection Kit (Real-time PCR)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081045
- Basic UDI-DI
- B-06970514081045
- Reference
- FCAPCR-25
- EMDN
- W0105060402
- EMDN description
- CANDIDA ALBICANS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07
06970514081038
Pneumocystis Molecular Detection Kit (Real-time PCR)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- Manufacturer SRN
- CN-MF-000027997
- UDI-DI
- 06970514081038
- Basic UDI-DI
- B-06970514081038
- Reference
- FPPCR-50
- EMDN
- W0105060405
- EMDN description
- PNEUMOCYSTIS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Caretechion GmbH
- Last updated
- 30.06.2026 04:07