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EUDAMED Device Search

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

Last updated

09.07.2026 23:38

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Estradiol Rapid Quantitative Test

Estradiol Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490367
Basic UDI-DI: B-06975679490367
Reference: E2
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

ALT/AST/ALB/TB Combo test kit

ALT/AST/ALB/TB Combo test kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490350
Basic UDI-DI: B-06975679490350
Reference: ALT/AST/ALB/TB
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

UA/CR/UREA Combo test kit

UA/CR/UREA Combo test kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490343
Basic UDI-DI: B-06975679490343
Reference: UA/CR/UREA
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

ALT/AST/UA/CR Combo test kit

ALT/AST/UA/CR Combo test kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490336
Basic UDI-DI: B-06975679490336
Reference: ALT/AST/UA/CR
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Glu/UA/TC/TG Combo test kit

Glu/UA/TC/TG Combo test kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490329
Basic UDI-DI: B-06975679490329
Reference: Glu/UA/TC/TG
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

HHV

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360303
Basic UDI-DI: B-06975578360303
Reference: 2000262
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

RP01

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360297
Basic UDI-DI: B-06975578360297
Reference: 2000260
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

TB01

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360211
Basic UDI-DI: B-06975578360211
Reference: 2000247
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

P11

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360204
Basic UDI-DI: B-06975578360204
Reference: 2000265
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

FS

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360198
Basic UDI-DI: B-06975578360198
Reference: 2000264
EMDN: W0105070202
EMDN description: BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

MP21

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360181
Basic UDI-DI: B-06975578360181
Reference: 2000263
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

SC

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360167
Basic UDI-DI: B-06975578360167
Reference: 2000261
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

P09

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360150
Basic UDI-DI: B-06975578360150
Reference: 2000244
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

MP02

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360143
Basic UDI-DI: B-06975578360143
Reference: 2000236
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

EM

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360129
Basic UDI-DI: B-06975578360129
Reference: 2000266
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Calcitonin

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76466GD
Basic UDI-DI: B-DC76466GD
Reference: DC76465
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Calcitonin

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76467GF
Basic UDI-DI: B-DC76467GF
Reference: DC76467
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α/β-Thalassemia Kit

PCR-CE α/β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886115
Basic UDI-DI: B-06975358886115
Reference: 04110023
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α/β-Thalassemia Kit

PCR-CE α/β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886108
Basic UDI-DI: B-06975358886108
Reference: 04110022
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE β-Thalassemia Kit

PCR-CE β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886016
Basic UDI-DI: B-06975358886016
Reference: 04110021
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details