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EUDAMED Device Search

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

Last updated

17.07.2026 02:19

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417 device results listed.

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BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214426
Basic UDI-DI: B-06933260214426
Reference: BT2501-HBA1C
EMDN: -
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT3 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214280
Basic UDI-DI: B-06933260214280
Reference: BT2214-FT3
EMDN: -
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214297
Basic UDI-DI: B-06933260214297
Reference: BT2501-HBA1C
EMDN: -
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214303
Basic UDI-DI: B-06933260214303
Reference: BT2212-E2
EMDN: -
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT4 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214310
Basic UDI-DI: B-06933260214310
Reference: BT2215-FT4
EMDN: -
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HCY Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214327
Basic UDI-DI: B-06933260214327
Reference: BT2221-HCY
EMDN: -
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214334
Basic UDI-DI: B-06933260214334
Reference: BT2211-TES
EMDN: -
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck PRL Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214341
Basic UDI-DI: B-06933260214341
Reference: BT2207-PRL
EMDN: -
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle 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: -
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck BNP Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214365
Basic UDI-DI: B-06933260214365
Reference: BT2109-BNP
EMDN: -
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214372
Basic UDI-DI: B-06933260214372
Reference: BT2102-Myo
EMDN: -
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214396
Basic UDI-DI: B-06933260214396
Reference: BT2101-cTnl
EMDN: -
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214389
Basic UDI-DI: B-06933260214389
Reference: CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EMDN: -
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CLi-3200

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214051
Basic UDI-DI: 69332602IT01000129W
Reference: BT0001001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

UAM-02

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214044
Basic UDI-DI: 69332602IT01000119U
Reference: BT0000901
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

BKM-02

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214037
Basic UDI-DI: 69332602IT01000109S
Reference: BT0000801
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

FLI-4000

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214020
Basic UDI-DI: 69332602IT01000139Y
Reference: BT0001101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

BGM-202

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260213221
Basic UDI-DI: 69332602IT0100009A9
Reference: BT0000701
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

FLI-600

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212361
Basic UDI-DI: 69332602IT0100006A3
Reference: BT0301
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

BL-100

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212354
Basic UDI-DI: 69332602IT0100008A7
Reference: BT0001501
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details