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

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173 device results listed.

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CSCQ Specimen 4

18008448

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683228
Basic UDI-DI: B-00810042683228
Reference: 18008448
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 05.08.2026 01:08

Manufacturer products Authorised representative products Authorised representative actors View details

ORAL-SKREEN Negative with Stabilizer, 500mL

20200200

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682665
Basic UDI-DI: B-00810042682665
Reference: 20200200
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 05.08.2026 01:08

Manufacturer products Authorised representative products Authorised representative actors View details

SSHMOBE with Butalbital Cutoff +50%, 20mL

18008327

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683242
Basic UDI-DI: B-00810042683242
Reference: 18008327
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

SSHMOBE with Butalbital Cutoff -50%, 20mL

18002824

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683235
Basic UDI-DI: B-00810042683235
Reference: 18002824
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

CSCQ Specimen 3

18008447

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683211
Basic UDI-DI: B-00810042683211
Reference: 18008447
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

CSCQ Specimen 2

IVD generalNot specifiedOn the market

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683204
Basic UDI-DI: B-00810042683204
Reference: 18008446
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

CSCQ Specimen 1

18008445

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683198
Basic UDI-DI: B-00810042683198
Reference: 18008445
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

HCG URINE CONTROL Negative/Low Positive 2x4mL

702012

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683181
Basic UDI-DI: B-00810042683181
Reference: 702012
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Low positive / Negative URINE 2x5mL Kitbox

18003155

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683174
Basic UDI-DI: B-00810042683174
Reference: 18003155
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

PREGNANCY-SKREEN hCG Liquid Control Serum -/+ 2x4mL

702033

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683167
Basic UDI-DI: B-00810042683167
Reference: 702033
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL

702032

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683150
Basic UDI-DI: B-00810042683150
Reference: 702032
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

SSHMOBE with BUTALBITAL 2x20ml

820001

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042683075
Basic UDI-DI: B-00810042683075
Reference: 820001
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

THC 1000ng, 100mL

18000454

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682986
Basic UDI-DI: B-00810042682986
Reference: 18000454
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

AUNZS19 Cutoff +50%, 20mL

18100157

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682979
Basic UDI-DI: B-00810042682979
Reference: 18100157
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

AUNZS19 Cutoff -50%, 20mL

18100156

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682955
Basic UDI-DI: B-00810042682955
Reference: 18100156
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

SSHMOBE with Butalbital 3X 100mL

18008284

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682931
Basic UDI-DI: B-00810042682931
Reference: 18008284
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

STAT-SKREEN Cutoff, 20mL

19470056

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682870
Basic UDI-DI: B-00810042682870
Reference: 19470056
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

CONFIRM 3, Cutoff -25%, 50mL

19582025

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682863
Basic UDI-DI: B-00810042682863
Reference: 19582025
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

GCMS-H Control, Cutoff -60%, 50mL

19572256

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682856
Basic UDI-DI: B-00810042682856
Reference: 19572256
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details

SERIES IV-H, Cutoff +25%, 20mL

19544756

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Biochemical Diagnostics, Inc
Manufacturer SRN: US-MF-000025179
UDI-DI: 00810042682849
Basic UDI-DI: B-00810042682849
Reference: 19544756
EMDN: W05039099
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 01.08.2026 10:33

Manufacturer products Authorised representative products Authorised representative actors View details