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

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107 device results listed.

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SDB HbA1c Control

C-A1C

IVD Class CIVDR 2017/746On the marketHuman tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725678
Basic UDI-DI: 88001117IPCA02FA05WA
Reference: 10A1CC20
EMDN: W0102160801
EMDN description: CONTROLS IMMUNOCHEM - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-FA05 · Rev. 03
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

STANDARD™ F HbA1c

F-A1C

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725661
Basic UDI-DI: 88001117IPCA01FA05VX
Reference: 10A1C20B
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-FA05 · Rev. 03
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

STANDARD™ i Vitamin D Total

i-VDT-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725081
Basic UDI-DI: 88001117IPBA01IA17W8
Reference: 16VITD10D
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i β-hCG

i-HCG-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724169
Basic UDI-DI: 88001117IPBA01IA15W4
Reference: 16BHC10D
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i LH

i-LH-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724138
Basic UDI-DI: 88001117IPBA01IA33W6
Reference: 16LH10D
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Testosterone

i-TET-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724077
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10D
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

08800111724046

i-INS-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724046
Basic UDI-DI: 88001117IPBA01IA38WG
Reference: 16INS10D
EMDN: W0102060103
EMDN description: INSULIN
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

08800111724015

i-E2-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724015
Basic UDI-DI: 88001117IPBA01IA14W2
Reference: 16E210D
EMDN: W0102050103
EMDN description: ESTRADIOL
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

i-CTS-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723483
Basic UDI-DI: 88001117IPCA01IA36WX
Reference: 16COR10D
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Austria
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 Prolactin

i-PRL-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723452
Basic UDI-DI: 88001117IPBA01IA13VY
Reference: 16PRL10D
EMDN: W0102050108
EMDN description: PROLACTIN
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

08800111723421

i-fT3-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723421
Basic UDI-DI: 88001117IPBA01IA20VV
Reference: 16FT310D
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
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

08800111723339

i-T4-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723339
Basic UDI-DI: 88001117IPBA01IA22VZ
Reference: 16T410D
EMDN: W01020407
EMDN description: THYROXINE
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 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