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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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135 device results listed.

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STANDARD™ i Vitamin B12

i-VB12-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722899
Basic UDI-DI: 88001117IPBA01IA18WA
Reference: 16VITB10D
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111716799

M10-CVFR-02

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111716799
Basic UDI-DI: 88001117IPBA01MA03WR
Reference: 11FLU30A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715778

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715778
Basic UDI-DI: 88001117IPBA04QA04YQ
Reference: Q-NCOV-07G/ 09COV176D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715761

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715761
Basic UDI-DI: 88001117IPBA02QA04Y2
Reference: Q-NCOV-07G/ 09COV175D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715754

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715754
Basic UDI-DI: 88001117IPBA03QA04YD
Reference: Q-NCOV-07G/ 09COV173D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

08800111715747

Q-NCOV-07G

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111715747
Basic UDI-DI: 88001117IPBA01QA04XP
Reference: Q-NCOV-07G/ 09COV172D
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723506
Basic UDI-DI: 88001117IPCA01IA36WX
Reference: 16COR10Q
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723490
Basic UDI-DI: 88001117IPCA01IA36WX
Reference: 16COR10F
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724145
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10F
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724152
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10Q
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i β-hCG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724176
Basic UDI-DI: 88001117IPBA01IA15W4
Reference: 16BHC10F
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Prolactin

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723469
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10F
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Prolactin

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723476
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10Q
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Vitamin D Total

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725098
Basic UDI-DI: 88001117IPBA01IA17W8
Reference: 16VITD10F
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Vitamin D Total

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725104
Basic UDI-DI: 88001117IPBA01IA17W8
Reference: 16VITD10Q
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724022

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724022
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210F
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724039

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724039
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210Q
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724053

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724053
Basic UDI-DI: 88001117IPBA01IA38WG
Reference: 16INS10F
EMDN: W0102060103
EMDN description: INSULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724060

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724060
Basic UDI-DI: 88001117IPBA01IA38WG
Reference: 16INS10Q
EMDN: W0102060103
EMDN description: INSULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

08800111723346

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723346
Basic UDI-DI: 88001117IPBA01IA22VZ
Reference: 16T410F
EMDN: W01020407
EMDN description: THYROXINE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details