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417 device results listed.

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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

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

Total IgE Rapid Quantitative Test (Fluorescence Immunoassay)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212378
Basic UDI-DI: B-06933260212378
Reference: BT2901
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A/B & COVID-19 Ag Combo Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208951
Basic UDI-DI: B-06933260208951
Reference: BT1781
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Control Set

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208869
Basic UDI-DI: B-06933260208869
Reference: BT0401001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPV Rapid Quantitative Test (eRDA)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208852
Basic UDI-DI: B-06933260208852
Reference: BT0300402
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPV Rapid Quantitative Test (eRDA)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208845
Basic UDI-DI: B-06933260208845
Reference: BT0300401
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208814
Basic UDI-DI: B-06933260208814
Reference: BT0201501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208807
Basic UDI-DI: B-06933260208807
Reference: BT0201401
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208791
Basic UDI-DI: B-06933260208791
Reference: BT0200304
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208784
Basic UDI-DI: B-06933260208784
Reference: BT0200303
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208777
Basic UDI-DI: B-06933260208777
Reference: BT0200302
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208760
Basic UDI-DI: B-06933260208760
Reference: BT0200301
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208753
Basic UDI-DI: B-06933260208753
Reference: BT0200201
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208746
Basic UDI-DI: B-06933260208746
Reference: BT0200101
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG/IgM Rapid Qualitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208739
Basic UDI-DI: B-06933260208739
Reference: BT1301
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208722
Basic UDI-DI: B-06933260208722
Reference: BT2109
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

HCY Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208715
Basic UDI-DI: B-06933260208715
Reference: BT2221
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208708
Basic UDI-DI: B-06933260208708
Reference: BT2306
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details