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222 device results listed.

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D-Dimer/FDP Test Kit (QDs-FICA)

1 pcs/box, 5 pcs/box, 10 pcs/box, 50 pcs/box and 100 pcs/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880003
Basic UDI-DI: B-06977981880003
Reference: AD1001
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: Share info GmbH
Last updated: 07.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

06975808410372

β-hydroxybutyrate acid Assay kit (Enzyme Chemical Reaction Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044320
UDI-DI: 06975808410372
Basic UDI-DI: B-06975808410372
Reference: 20 tests/box
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975808410259

oxidase, Lactic acid, Bacterial Endotoxin Assay kit (Enzyme Chemical Reaction Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044320
UDI-DI: 06975808410259
Basic UDI-DI: B-06975808410259
Reference: 1 test/box
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

06975808410068

Vaginitis Screen Kit (Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044320
UDI-DI: 06975808410068
Basic UDI-DI: B-06975808410068
Reference: 1 test/box
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

06975808410006

Vaginitis/Bacterial Vaginosis Combination Test Kit (Enzyme Chemical Reaction Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044320
UDI-DI: 06975808410006
Basic UDI-DI: B-06975808410006
Reference: 1 test/box
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

tHb Kit(Colorimetry)

tHb Kit

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Chengdu Polytech Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000034373
UDI-DI: 06975429090335
Basic UDI-DI: B-06975429090335
Reference: MD20368
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

NGEx

NGEx FFPE DNA Purification Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Oncodia AB
Manufacturer SRN: SE-MF-000023836
UDI-DI: 17350143380119
Basic UDI-DI: 735014338ES-S110FP-CE7
Reference: ES-S110FP-C
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:12

Manufacturer products View details

NGEx

NGEx FFPE DNA Purification Kit

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Oncodia AB
Manufacturer SRN: SE-MF-000023836
UDI-DI: 17350143380010
Basic UDI-DI: 735014338NGExFFPEDNADX
Reference: ES-K110FP-C
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:12

Manufacturer products View details

GeneMind

96 tests/kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583551
Basic UDI-DI: 69749685896RXNSD
Reference: L000108
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cell-Free DNA Isolation Kit (Magnetic Beads Method)

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583094
Basic UDI-DI: 697496858C-KitVL
Reference: L000028
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

NeoBase 2 Non-derivatized MSMS kit

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147356805
Basic UDI-DI: 6438147MSMS_NeoBase24D
Reference: 3044-0010
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

ClinRep® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum

25-Hydroxy-Vitamin D2/D3 in Plasma and Serum

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195350008
Basic UDI-DI: 4049195B35X00C4
Reference: 35000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit for Vitamin B1 in Whole Blood

Vitamin B1, B2 in Whole Blood, B6 in Plasma / Whole Blood

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195240002
Basic UDI-DI: 4049195B24000-27000NG
Reference: 24000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit for Homocysteine in Plasma

Homocysteine in Plasma

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195230003
Basic UDI-DI: 4049195B2300058
Reference: 23000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit for Vitamin A and E in Serum / Plasma

Vitamin A and E in Serum / Plasma

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195220004
Basic UDI-DI: 4049195B22X00B4
Reference: 22000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum

Carbohydrate-deficient Transferrin

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195210005
Basic UDI-DI: 4049195B21X00AV
Reference: 21000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit, advanced,for Antiepileptics in Serum / Plasma

Antiepileptics in Serum / Plasma

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195140005
Basic UDI-DI: 4049195C14X00BL
Reference: 14000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinRep® Complete Kit for Catecholamines Plasma

Biogenic Amines

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195010001
Basic UDI-DI: 4049195B1000-6000FQ
Reference: 1000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ClinMass® Add-on Set for Antibiotics in Serum / Plasma

ANTIBIOTICS IN SERUM / PLASMA, TDM - KIT SYSTEM

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195007162
Basic UDI-DI: 4049195CMS9700ME
Reference: MS9700
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:56

Manufacturer products View details

ClinDART® Complete Kit for Mycophenolic Acid in Serum and Plasma

MYCOPHENOLIC ACID IN SERUM / PLASMA, TDM, DART - MS/MS

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195008329
Basic UDI-DI: 4049195CMS100000KF
Reference: MS100000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:56

Manufacturer products View details