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417 device results listed.

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06933260214051

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

06933260214044

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

06933260214037

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

06933260214020

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

06933260213221

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

BIOTIME

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

06933260212354

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

06933260212347

HLC-100

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212347
Basic UDI-DI: 69332602IT0100007A5
Reference: BT0000601
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

BIOTIME

CLi-1600

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260211388
Basic UDI-DI: 69332602IT01000059Z
Reference: BT0000401
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

BIOTIME

ICE-100E

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260211371
Basic UDI-DI: 69332602IT01000019R
Reference: BTOHW
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

06933260209088

BIOT-YG-I

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209088
Basic UDI-DI: 69332602IT01000049X
Reference: BT0104
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

06933260209071

FLI-110

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209071
Basic UDI-DI: 69332602IT0100014A2
Reference: BT0000201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

06933260209064

FLI-100

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209064
Basic UDI-DI: 69332602IT01000029T
Reference: BT0106
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

06933260208586

AMH Rapid Quantitative Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208586
Basic UDI-DI: 69332602IF0100044ZW
Reference: BT0208801
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck BNP Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalNot specifiedNo longer on 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: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details