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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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MyoCheck BNP Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214365
Basic UDI-DI: B-06933260214365
Reference: BT2109-BNP
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214358
Basic UDI-DI: B-06933260214358
Reference: BT2105-D-Dimer
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck PRL Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214341
Basic UDI-DI: B-06933260214341
Reference: BT2207-PRL
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214334
Basic UDI-DI: B-06933260214334
Reference: BT2211-TES
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HCY Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214327
Basic UDI-DI: B-06933260214327
Reference: BT2221-HCY
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214303
Basic UDI-DI: B-06933260214303
Reference: BT2212-E2
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214297
Basic UDI-DI: B-06933260214297
Reference: BT2501-HBA1C
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT3 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214280
Basic UDI-DI: B-06933260214280
Reference: BT2214-FT3
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT4 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214310
Basic UDI-DI: B-06933260214310
Reference: BT2215-FT4
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

Anaerobic Blood Culture Bottles

Standard Anaerobic bottles for adult(Chromogenic Detection Method)

IVD generalIVDDNo longer on the marketCompanion diagnosticsProfessional testingSingle use

Manufacturer: RECOVERY (HK) TECHNOLOGY LIMITED
Manufacturer SRN: HK-MF-000048304
UDI-DI: 04897147600035
Basic UDI-DI: B-04897147600035
Reference: CSY-02001
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Aerobic Culture Bottles

Standard Aerobic Bottle for adult(Chromogenic Detection Method)

IVD generalIVDDNo longer on the marketCompanion diagnosticsProfessional testingSingle useSterile

Manufacturer: RECOVERY (HK) TECHNOLOGY LIMITED
Manufacturer SRN: HK-MF-000048304
UDI-DI: 04897147600028
Basic UDI-DI: B-04897147600028
Reference: CSY-01001
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920411

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920411
Basic UDI-DI: B-04897036920411
Reference: 92042
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920404

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920404
Basic UDI-DI: B-04897036920404
Reference: 92041
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920398

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920398
Basic UDI-DI: B-04897036920398
Reference: 92040
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920381

24 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920381
Basic UDI-DI: B-04897036920381
Reference: 92039
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760283

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760283
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760290

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760290
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760245

General

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760245
Basic UDI-DI: 697780576HSTAALIBMG6J
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

06977805760214

AA05-01-24S

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Health SwifTech Co., Ltd.
Manufacturer SRN: CN-MF-000044339
UDI-DI: 06977805760214
Basic UDI-DI: 697780576HSTAALIBMDK
Reference: AA05-01-24S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning Solution(Direct Method)

1×20mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595776867
Basic UDI-DI: 693659570132MS
Reference: BF0132P
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details