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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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09.07.2026 07:07

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Active filter:Manufacturer SRN:CN-MF-000001098

20 device results listed.

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Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146603665
Basic UDI-DI: B-06975146603665
Reference: 100 tests/kit
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00520

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600275
Basic UDI-DI: B-06975146600275
Reference: MPX00520
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00505

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600268
Basic UDI-DI: B-06975146600268
Reference: MPX00505
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00501

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600251
Basic UDI-DI: B-06975146600251
Reference: MPX00501
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00420

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600244
Basic UDI-DI: B-06975146600244
Reference: MPX00420
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00405

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600237
Basic UDI-DI: B-06975146600237
Reference: MPX00405
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00401

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600220
Basic UDI-DI: B-06975146600220
Reference: MPX00401
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00320

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600213
Basic UDI-DI: B-06975146600213
Reference: MPX00320
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00305

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600206
Basic UDI-DI: B-06975146600206
Reference: MPX00305
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00301

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600190
Basic UDI-DI: B-06975146600190
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00220

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600183
Basic UDI-DI: B-06975146600183
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPX00205

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600176
Basic UDI-DI: B-06975146600176
Reference: MPX00205
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPX00201

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600169
Basic UDI-DI: B-06975146600169
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00120

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600152
Basic UDI-DI: B-06975146600152
Reference: MPX00120
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00105

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600145
Basic UDI-DI: B-06975146600145
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

MPX00101

IVD generalIVDDOn the marketReagentSingle use

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600138
Basic UDI-DI: B-06975146600138
Reference: MPX00101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagent

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600039
Basic UDI-DI: B-06975146600039
Reference: 100 tests/kit
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600022
Basic UDI-DI: B-06975146600022
Reference: 20 tests/package
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600015
Basic UDI-DI: B-06975146600015
Reference: 5tests/package
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid SARS-CoV-2 Antigen Test Card

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testing

Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001098
UDI-DI: 06975146600008
Basic UDI-DI: B-06975146600008
Reference: 1 test/package
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details