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Multi-Drug 9 Drugs Test Panel(Urine)

DOA-194a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910529
Basic UDI-DI: 69798909110064D5
Reference: DOA-194a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 10 Drugs Test Panel(Urine)

DOA-1104a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910512
Basic UDI-DI: 69798909110065D7
Reference: Multi-Drug 10 Drugs Test Panel(Urine)
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 11 Drugs Test Panel(Urine)

DOA-1114a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910499
Basic UDI-DI: 69798909110066D9
Reference: DOA-1114a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 12 Drugs Test Panel(Urine)

DOA-1124a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910482
Basic UDI-DI: 69798909110067DB
Reference: DOA-1124a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer

CH B

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778703
Basic UDI-DI: 697806677SE004NU
Reference: 6620-PA00002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Calibrator

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778512
Basic UDI-DI: 697806677PR007QU
Reference: 7090-PA00002
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-INSTANT

25T/kit

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou ELIT Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000043511
UDI-DI: 06976667950030
Basic UDI-DI: 697666795DOAZ8
Reference: EDOA-124~1144
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Türkiye
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin Hemolytic Agent

Please see the IFU

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Hotgen (Langfang) Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018899
UDI-DI: 06936700408508
Basic UDI-DI: 697541776017MX
Reference: HGOTHER01
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Reagent (Immunonephelometric Method)

R ：1×13mL （75mm×45mm×105mm）

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454118
Basic UDI-DI: 6970493090506007P5
Reference: MY-0001-02
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ TSH

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390434857
Basic UDI-DI: 69713904303037P
Reference: 010303401
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098942
Basic UDI-DI: 697049309W01023007042CP
Reference: XQ-0010-01
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - 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

Serum Amyloid A Protein Control

1×1.0mL（Control 1）

IVD Class CIVDR 2017/746On the marketDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098911
Basic UDI-DI: 6970493090506005NZ
Reference: MY-0006-01
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 1）

IVD Class CIVDR 2017/746On the marketDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098409
Basic UDI-DI: 6970493090506006P3
Reference: MY-0005-01
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
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

C-Reactive Protein Calibrator

1×0.5mL（Calibrator 1）

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098270
Basic UDI-DI: 6970493090506003NV
Reference: MY-0002-02
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
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

C-Reactive Protein Control

1×1.0mL（Control 1）

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097174
Basic UDI-DI: 6970493090506002NT
Reference: MY-0003-02
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Serum Amyloid A Protein Reagent(Immunonephelometric Method)

R 1×13mL

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097051
Basic UDI-DI: 6970493090506004NX
Reference: MY-0004-01
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - 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

pro-Gastrin-Releasing Peptide (eCLIA)

50T, 2x50T, 100T, 2x100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341686017
Basic UDI-DI: 69703416803205051JC
Reference: 0320501301
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

free TESTO (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: 06978139075098
Basic UDI-DI: 69703416803205076JU
Reference: 0320514702
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
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

Renin (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: 06975984067148
Basic UDI-DI: 69703416803205109JJ
Reference: 0320511903
EMDN: W0102060204
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
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

ALD (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: 06975984067063
Basic UDI-DI: 69703416803205110J3
Reference: 0320511801
EMDN: W0102060201
EMDN description: ALDOSTERONE
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