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417 device results listed.

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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

BIOTIME

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208692
Basic UDI-DI: B-06933260208692
Reference: BT2801
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
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

PGI/ PGII Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208685
Basic UDI-DI: B-06933260208685
Reference: BT21003
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - 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

PGII Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208678
Basic UDI-DI: B-06933260208678
Reference: BT21002
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - 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

PGI Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208661
Basic UDI-DI: B-06933260208661
Reference: BT21001
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - 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

E2 Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208630
Basic UDI-DI: B-06933260208630
Reference: BT2212
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - 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

CEA/AFP Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208616
Basic UDI-DI: B-06933260208616
Reference: BT2403
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - 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

Cys-C Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208609
Basic UDI-DI: B-06933260208609
Reference: BT2602
EMDN: W0102019008
EMDN description: CYSTATIN C
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

NGAL Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208593
Basic UDI-DI: B-06933260208593
Reference: BT2603
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

SAA Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208579
Basic UDI-DI: B-06933260208579
Reference: BT2303
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

Ferritin Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208562
Basic UDI-DI: B-06933260208562
Reference: BT2701
EMDN: W0102070102
EMDN description: FERRITIN
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

CEA Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208555
Basic UDI-DI: B-06933260208555
Reference: BT2401
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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