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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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Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252064
Basic UDI-DI: B-06976232252064
Reference: CA03-65-422
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252040
Basic UDI-DI: B-06976232252040
Reference: CA03-41-422P25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252033
Basic UDI-DI: B-06976232252033
Reference: CA02-11-322P25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252019
Basic UDI-DI: B-06976232252019
Reference: CA03-19-422P25
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

ACMEX

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251999
Basic UDI-DI: B-06976232251999
Reference: CA03-53-422P25
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251982
Basic UDI-DI: B-06976232251982
Reference: CA03-57-422P20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251876
Basic UDI-DI: B-06976232251876
Reference: CA05-07-422P25
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251869
Basic UDI-DI: B-06976232251869
Reference: CA05-02-422P25
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251838
Basic UDI-DI: B-06976232251838
Reference: CA03-17-422P25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251807
Basic UDI-DI: B-06976232251807
Reference: CA01-12-422P25
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Accufast

Strip

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232251760
Basic UDI-DI: B-06976232251760
Reference: CA01-11-113P10
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

BV Diagnostic Kit (Sialidase Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235845043
Basic UDI-DI: B-06972235845043
Reference: LTB0101B
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

BV Diagnostic Kit (Sialidase Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235845036
Basic UDI-DI: B-06972235845036
Reference: LTB0101A
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

lambda-FLC Control Level 2

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936969
Basic UDI-DI: B-06971225936969
Reference: DM093H
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Liver Function Lyophilized Kit 12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996097338
Basic UDI-DI: B-06950996097338
Reference: LF-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Health Check Lyophilized Kit 19

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996060400
Basic UDI-DI: B-06950996060400
Reference: SYN-004
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Renal Function Lyophilized Kit 9

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996045995
Basic UDI-DI: B-06950996045995
Reference: KF-003
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Clinical Emergency Lyophilized Kit 12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996033657
Basic UDI-DI: B-06950996033657
Reference: EC-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Cardiovascular Risk Marker Lyophilized Kit 5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996022750
Basic UDI-DI: B-06950996022750
Reference: CAR-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Electrolytes Lyophilized Kit 9

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996011686
Basic UDI-DI: B-06950996011686
Reference: ELE-001
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details