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Hematology Calibrator

Model:DM-CAL-5E Specification:3mL×1、3mL×2、3mL×3

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493091998
Basic UDI-DI: 697049309W01033012000C2
Reference: XQ-0068-01
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

Model:DM-RET Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL×(N)1 、3 mL(N)×2 、3 mL (N)×3、3 mL(L)×1 、3 mL(L)×2 、3 mL(L)×3 、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×1

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493091899
Basic UDI-DI: 697049309W01033012003C8
Reference: XQ-0070-01
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

LYN-G:1L

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493091875
Basic UDI-DI: 697049309W01030000006A2
Reference: 12.01.1346A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Dye

FDN-R:24mL

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493091851
Basic UDI-DI: 697049309W010300000059Y
Reference: 12.01.1325A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 STAT (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064017
Basic UDI-DI: 69703416803205094JW
Reference: IL-6 STAT (eCLIA)
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer STAT (eCLIA)

50T，2×50T，100T，2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341688035
Basic UDI-DI: 69703416803205040J7
Reference: 0320500303
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Assay Kit

ETGS8601M

IVD Class CIVDR 2017/746Not intended for EU marketKitReagent

Manufacturer: Beijing Strong Biotechnologies, Inc.
Manufacturer SRN: CN-MF-000004362
UDI-DI: 06936736067700
Basic UDI-DI: 697030147BSBE0001H9
Reference: ETGS8601M
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin-6 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403152
Basic UDI-DI: 697029753049LG
Reference: HGCL10
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403114
Basic UDI-DI: 697029753047LC
Reference: HGCL05
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547710
Basic UDI-DI: 697015090000044H4
Reference: CMH0505
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547697
Basic UDI-DI: 697015090000044H4
Reference: CMH0503
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

p16/ Ki-67 dual stain cytology kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304816
Basic UDI-DI: 695593130025060001KX
Reference: 250601
EMDN: W01030711
EMDN description: IMMUNOHISTOLOGY KITS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

DD Nucleic Acid Dye

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

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304717
Basic UDI-DI: 695593130025040001K9
Reference: 250401
EMDN: W01030702
EMDN description: CYTOCHEMICAL STAINING REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Immersion Oil

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Baso Diagnostics Inc. Zhuhai
Manufacturer SRN: CN-MF-000050424
UDI-DI: 06952383305460
Basic UDI-DI: 695238330005GK
Reference: 1000ml
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

DPX (PHTHALATE FREE) MOUNTING MEDIUM – 1L