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EUDAMED Device Search

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

Last updated

23.09.2026 19:49

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268 device results listed.

Page 8 / 14

AFP Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808110-19R
Basic UDI-DI: B-808110-19R
Reference: 808110-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808086-1BV
Basic UDI-DI: B-808086-1BV
Reference: 808086-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808085-1BQ
Basic UDI-DI: B-808085-1BQ
Reference: 808085-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808073-1B7
Basic UDI-DI: B-808073-1B7
Reference: 808073-1
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808072QG
Basic UDI-DI: B-808072QG
Reference: 808072
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808052-1AL
Basic UDI-DI: B-808052-1AL
Reference: 808052-1
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

PROFAR Test PSA

PROFAR TEST PSA

IVD Annex II List BIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801080NW
Basic UDI-DI: B-801080NW
Reference: 801080
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

PROFAR TEST COLON RETTO

Profar Test Colon Retto

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-801040NJ
Basic UDI-DI: B-801040NJ
Reference: 801040
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

800040-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800040-1CS2T
Basic UDI-DI: B-800040-1CS2T
Reference: 800040-1CS
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245295
Basic UDI-DI: B-15065026245295
Reference: TV20042
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

FOB-TRF Combo Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763259
Basic UDI-DI: B-15065023763259
Reference: TV10026
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763235
Basic UDI-DI: B-15065023763235
Reference: TV10024
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fortel Prostate (PSA) Screening Test

1081-1

IVD Annex II List BIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: D-1081-1LS
Basic UDI-DI: B-1081-1LS
Reference: 1081-1
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 03:18

Manufacturer products View details

SOFTEC Creatine Kinase-MB Rapid Test Kit

SFCKMB40

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616299
Basic UDI-DI: B-08697962616299
Reference: SFCKMB
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187751
Basic UDI-DI: B-08693285187751
Reference: TIHHB02001
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187638
Basic UDI-DI: B-08693285187638
Reference: TIHHB01001
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187393
Basic UDI-DI: B-08693285187393
Reference: TIHHB02010
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187119
Basic UDI-DI: B-08693285187119
Reference: TIHHB02
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187102
Basic UDI-DI: B-08693285187102
Reference: TIHHB01
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

Fecal Occult Blood (FOB) Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285185818
Basic UDI-DI: B-08693285185818
Reference: RTHHB03
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:30

Manufacturer products View details