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07.07.2026 00:24

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121 device results listed.

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R1: 2×60 mL, R2: 2×15 mL, Calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129599
Basic UDI-DI: B-06974760129599
Reference: R1: 2×60 mL, R2: 2×15 mL, Calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional)
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×54 mL, R2: 2×10 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129582
Basic UDI-DI: B-06974760129582
Reference: R1: 2×54 mL, R2: 2×10 mL
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×54 mL, R2: 2×10 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129575
Basic UDI-DI: B-06974760129575
Reference: R1: 2×54 mL, R2: 2×10 mL
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129568
Basic UDI-DI: B-06974760129568
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129551
Basic UDI-DI: B-06974760129551
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129544
Basic UDI-DI: B-06974760129544
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×45 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129537
Basic UDI-DI: B-06974760129537
Reference: R1: 2×45 mL, R2: 2×15 mL
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129520
Basic UDI-DI: B-06974760129520
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1×16 mL, R2: 1×4 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129490
Basic UDI-DI: B-06974760129490
Reference: R1: 1×16 mL, R2: 1×4 mL
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×54 mL, R2: 2×18 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129513
Basic UDI-DI: B-06974760129513
Reference: R1: 2×54 mL, R2: 2×18 mL
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×45 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129506
Basic UDI-DI: B-06974760129506
Reference: R1: 2×45 mL, R2: 2×15 mL
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

GA: R1: 1×20 mL, R2: 1×5 mL, ALB: R1: 1×22 mL, R2: 1×11 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129414
Basic UDI-DI: B-06974760129414
Reference: 942
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1×16 mL, R2: 1×8 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129315
Basic UDI-DI: B-06974760129315
Reference: R1: 1×16 mL, R2: 1×8 mL
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ST-280p

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300698
Basic UDI-DI: 69372873AMTECHSTEN
Reference: ST-280p
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300681
Basic UDI-DI: B-06937287300681
Reference: 100 tests/kit
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300674
Basic UDI-DI: B-06937287300674
Reference: 100 tests/kit
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300667
Basic UDI-DI: B-06937287300667
Reference: 100 tests/kit
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300650
Basic UDI-DI: B-06937287300650
Reference: 100 tests/kit
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300643
Basic UDI-DI: B-06937287300643
Reference: 100 tests/kit
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300636
Basic UDI-DI: B-06937287300636
Reference: R1: 2×60 mL
EMDN: W0102039018
EMDN description: ALPHA-FUCOSIDASE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details