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06972221450657

48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450657
Basic UDI-DI: 697222145067FW
Reference: 48 tests/kit, 96 tests/kit, 32 tests/kit (pre-packaged), 96 tests/kit (pre-packaged)
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450282

100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); 12 tubes/box (3 mL/tube); 12 tubes/box (6 mL/tube)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450282
Basic UDI-DI: 697222145028FL
Reference: 100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); etc.
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem PA

AutoChem analyzer

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

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253001233
Basic UDI-DI: 69422530000013N7
Reference: 360101PA0000F
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 10:36

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AutoChem ISE Diluent

AutoChem

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942253000052
Basic UDI-DI: 69422530000131NE
Reference: 360115SED0003
EMDN: W01019002
EMDN description: ELECTROPHORESIS MEDIA (UNASSIGNABLE)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaner / Wash Concentrate / Rinse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384614015
Basic UDI-DI: 69383846XQ065Y4
Reference: 33-40-E001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse for Hematology Analyzers Use

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384612011
Basic UDI-DI: 69383846XQ064Y2
Reference: L-03H78-01
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Diluents for Hematology Analyzers Use

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384611014
Basic UDI-DI: 69383846XQ063XY
Reference: L-03H79-01
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Alkali Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595760538
Basic UDI-DI: 693659579900QL
Reference: 9900Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Acid Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595760521
Basic UDI-DI: 693659579902QQ
Reference: 9902Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Hitergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595759839
Basic UDI-DI: 693659579901QN
Reference: 9901Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595758351
Basic UDI-DI: 693659579909R6
Reference: 9909Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595758344
Basic UDI-DI: 69365957033YX
Reference: ISE033Y
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Acid Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595759495
Basic UDI-DI: 693659579904QU
Reference: 9904Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Alkali Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595759488
Basic UDI-DI: 693659579903QS
Reference: 9903Y
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Concentrated Wash Solution

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595748390
Basic UDI-DI: 693659579905QW
Reference: 9905Y
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

NeoLSD LC-MSMS Eluents

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147407835
Basic UDI-DI: 6438147LC-MSMS_Eluents4H
Reference: 3258-0010
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NeoLSD LC-MSMS Assay Solutions

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147407828
Basic UDI-DI: 6438147LC-MSMS_SolRY
Reference: 3257-0010
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic DNA Plasma200 kit (MSM I)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147364916
Basic UDI-DI: 6438147chemagic_P3R
Reference: 3097-0020
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic DNA Blood200 kit (MSM I)

chemagic DNA Blood200 kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147364909
Basic UDI-DI: 6438147chemagic_B2V
Reference: 3095-0020
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NeoBase 2 Non-derivatized Assay Solutions

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147348107
Basic UDI-DI: 6438147MSMS_NeoBase2SQA
Reference: 3045-0010
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details