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EUDAMED Device Search

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

Last updated

22.09.2026 04:45

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Active filter:EMDN:W0102152205

85 device results listed.

Page 3 / 5

0.5 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100748
Basic UDI-DI: B-06974671100748
Reference: DR-CAL-CM-A009
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

1.0 mL/ vial, 6 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100731
Basic UDI-DI: B-06974671100731
Reference: DR-CAL-CM-A007
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

1.0 mL/ vial, 6 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100724
Basic UDI-DI: B-06974671100724
Reference: DR-CAL-CM-A006
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

1.0 mL/vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100717
Basic UDI-DI: B-06974671100717
Reference: DR-CAL-CM-A002
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100700
Basic UDI-DI: B-06974671100700
Reference: DR-CAL-CM-A001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

CLIA CEA Calibrator

CLIA CEA Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001164
Basic UDI-DI: B-06974521001164
Reference: CAL026
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

CLIA AFP Calibrator

CLIA AFP Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001133
Basic UDI-DI: B-06974521001133
Reference: CAL025
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Free PSA Calibrator

Boditech Free PSA Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048528
Basic UDI-DI: 880613307141D7
Reference: CFPO-409
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech PSA Calibrator

Boditech PSA Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048504
Basic UDI-DI: 880613307011CR
Reference: CFPO-277
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Inhibin B Gen II Calibrators and Controls

A81304

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590206840
Basic UDI-DI: 150995905A81304SW
Reference: A81304
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Czechia
Authorised representative: -
Last updated: 01.07.2026 11:52

Manufacturer products View details

Access OV Monitor (Calibrators)

386358

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232375
Basic UDI-DI: 150995901AccOVMonCalTC
Reference: 386358
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech free PSA (Calibrators)

37215

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232337
Basic UDI-DI: 150995901AccHfPSACalDL
Reference: 37215
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Access BR Monitor (Calibrators)

387647

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231866
Basic UDI-DI: 150995901AccBRMonCalHH
Reference: 387647
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Access GI Monitor (Calibrators)

387688

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231835
Basic UDI-DI: 150995901AccGIMonCalFP
Reference: 387688
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP (Calibrators)

33215

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231484
Basic UDI-DI: 150995901AccAFPCalZH
Reference: 33215
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech PSA (Calibrator)

37205

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224585
Basic UDI-DI: 150995901AccHPSACalYN
Reference: 37205
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech p2PSA (Calibrators)

A49753

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590204129
Basic UDI-DI: 150995901AccHp2PSACalBP
Reference: A49753
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:35

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech iFOB Neo Calibrator

Boditech iFOB Neo Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048979
Basic UDI-DI: 880613307142D9
Reference: CFPO-379
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo PIVKA-II CLIA Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177759
Basic UDI-DI: 697015090000083HE
Reference: CA061001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo CA19-9 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177742
Basic UDI-DI: 697015090000010GK
Reference: CA060401
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details