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EUDAMED Device Search

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72 device results listed.

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CA72-4 Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrCA724402F58
Basic UDI-DI: B-acrCA724402F58
Reference: acrCA724402F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TBT-ACO1029G
Basic UDI-DI: B-TBT-ACO1029G
Reference: TBT-ACO102
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TCE-R402EW
Basic UDI-DI: B-TCE-R402EW
Reference: TCE-R402
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.08.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TAF-R402E9
Basic UDI-DI: B-TAF-R402E9
Reference: TAF-R402
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.08.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Rapid Tests

TCEA4001 TCEA4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-TCEA400WL
Basic UDI-DI: B-TCEA400WL
Reference: TCEA4001 TCEA4002
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Rapid Tests

TAFP4001, TAFP4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-TAFP400ZE
Basic UDI-DI: B-TAFP400ZE
Reference: TAFP4001, TAFP4002
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

(CEA) Carcinoembryonic Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140266
Basic UDI-DI: B-06958982140266
Reference: AE40-11
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Cyprus
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Tests

Strip & Cassette

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140044
Basic UDI-DI: B-06958982140044
Reference: E20-11
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 05.08.2026 14:39

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA21-1 Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CA211-402X7
Basic UDI-DI: B-ACO-CA211-402X7
Reference: ACO-CA211-402
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

06941571843006

R43-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571843006
Basic UDI-DI: B-06941571843006
Reference: R43-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571842009

R42-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571842009
Basic UDI-DI: B-06941571842009
Reference: R42-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:55

Manufacturer products Authorised representative products Authorised representative actors View details

06941571820502

SQ20-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571820502
Basic UDI-DI: B-06941571820502
Reference: SQ20-116
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941571820403

SQ20-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571820403
Basic UDI-DI: B-06941571820403
Reference: SQ20-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941571820304

R20-116

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571820304
Basic UDI-DI: B-06941571820304
Reference: R20-116
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941571820205

R20-112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571820205
Basic UDI-DI: B-06941571820205
Reference: R20-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941571820106

R20-110

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571820106
Basic UDI-DI: B-06941571820106
Reference: R20-110
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941571800603

SQ00-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800603
Basic UDI-DI: B-06941571800603
Reference: SQ00-116
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

06941571800504

SQ00-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800504
Basic UDI-DI: B-06941571800504
Reference: SQ00-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

06941571800405

R00-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800405
Basic UDI-DI: B-06941571800405
Reference: R00-116
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

06941571800306

R00-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800306
Basic UDI-DI: B-06941571800306
Reference: R00-112
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details