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06.07.2026 07:34

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70 device results listed.

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Dry Biochemistry Immunoassay Analyzer

NIR-2000C

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491227
Basic UDI-DI: 6975068492040010U6
Reference: CP119.B1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluoroimmunoassay Analyzer

NIR-2000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068491005
Basic UDI-DI: 6975068492010020T8
Reference: CP088.B1
EMDN: W0202030201
EMDN description: IMMUNOHEMATOLOGY READERS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluoroimmunoassay Analyzer

NIR-1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490251
Basic UDI-DI: 6975068492010010T5
Reference: CP011.B1
EMDN: W0202030201
EMDN description: IMMUNOHEMATOLOGY READERS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test Kit（Colloidal Gold）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490022
Basic UDI-DI: B-06975068490022
Reference: CP044.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total Triiodothyronine（TT3）Rapid Quantitative Test（Fluorescence immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490268
Basic UDI-DI: B-06975068490268
Reference: CP058.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total Thyroxine（TT4）Rapid Quantitative Test（Fluorescence immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490275
Basic UDI-DI: B-06975068490275
Reference: CP059.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490282
Basic UDI-DI: B-06975068490282
Reference: CP068.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Stimulating Hormone（TSH）Rapid Quantitative Test（Fluorescence immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490299
Basic UDI-DI: B-06975068490299
Reference: CP060.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone（TESTO）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490305
Basic UDI-DI: B-06975068490305
Reference: CP071.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin（PRL）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490312
Basic UDI-DI: B-06975068490312
Reference: CP069.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone（Prog）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490329
Basic UDI-DI: B-06975068490329
Reference: CP070.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅱ（PGⅡ）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490336
Basic UDI-DI: B-06975068490336
Reference: CP057.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅰ（PGⅠ）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490343
Basic UDI-DI: B-06975068490343
Reference: CP056.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone（LH）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490350
Basic UDI-DI: B-06975068490350
Reference: CP064.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin（INS）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490367
Basic UDI-DI: B-06975068490367
Reference: CP080.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori（HP）Antigen Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490374
Basic UDI-DI: B-06975068490374
Reference: CP083.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine（FT3）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490381
Basic UDI-DI: B-06975068490381
Reference: CP062.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine（FT4）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490398
Basic UDI-DI: B-06975068490398
Reference: CP063.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone（FSH）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490404
Basic UDI-DI: B-06975068490404
Reference: CP065.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Folic Acid（FA）Rapid Quantitative Test（Fluorescence Immunoassay）

-

IVD generalNot specifiedOn the market

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490411
Basic UDI-DI: B-06975068490411
Reference: CP022.B1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details