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417 device results listed.

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hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260204656
Basic UDI-DI: B-06933260204656
Reference: BT0501202
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260204663
Basic UDI-DI: B-06933260204663
Reference: BT0501203
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

PLGF Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205998
Basic UDI-DI: B-06933260205998
Reference: BT0503901
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

INS Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260206049
Basic UDI-DI: B-06933260206049
Reference: BT0504001
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

INS Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260206056
Basic UDI-DI: B-06933260206056
Reference: BT0504002
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207305
Basic UDI-DI: B-06933260207305
Reference: BT0505904
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207312
Basic UDI-DI: B-06933260207312
Reference: BT0505905
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207329
Basic UDI-DI: B-06933260207329
Reference: BT0506001
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207350
Basic UDI-DI: B-06933260207350
Reference: BT0506004
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Rapid Quantitative Test (Chemiluminescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260207466
Basic UDI-DI: B-06933260207466
Reference: BT0506405
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208470
Basic UDI-DI: B-06933260208470
Reference: BT2301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

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: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

MPV Quantitative Test (Realtime PCR)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208838
Basic UDI-DI: B-06933260208838
Reference: BT0300301
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 09.08.2026 23:19

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: 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: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle 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: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle 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: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle 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: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

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