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936 device results listed.

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AutoLumo CYFRA 21-1 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177230
Basic UDI-DI: 697015090000226HC
Reference: CA061801
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo CA50 Calibrators

CA50 CLIA Microparticles

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177223
Basic UDI-DI: 697015090000225HA
Reference: CA061701
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Pepsinogen Ⅱ Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177216
Basic UDI-DI: 697015090000230H3
Reference: CA061601
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo Pepsinogen Ⅰ Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177209
Basic UDI-DI: 697015090000229HJ
Reference: CA061501
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo NT-proBNP Calibrators

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177179
Basic UDI-DI: 697015090000038H9
Reference: CA140101
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

7×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5, Calibrator 6, Calibrator 7）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098904
Basic UDI-DI: B-06970493098904
Reference: MY-0005-09
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 7）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098898
Basic UDI-DI: B-06970493098898
Reference: MY-0005-07
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 6）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098881
Basic UDI-DI: B-06970493098881
Reference: MY-0005-06
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

5×0.5mL（Calibrator 1, Calibrator 2, Calibrator 3, Calibrator 4, Calibrator 5）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098874
Basic UDI-DI: B-06970493098874
Reference: MY-0005-08
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 5）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098690
Basic UDI-DI: B-06970493098690
Reference: MY-0005-05
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 4）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098430
Basic UDI-DI: B-06970493098430
Reference: MY-0005-04
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 3）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098423
Basic UDI-DI: B-06970493098423
Reference: MY-0005-03
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Calibrator

1×0.5mL（Calibrator 2）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098416
Basic UDI-DI: B-06970493098416
Reference: MY-0005-02
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 30.06.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Calibrator

5×1mL

IVD generalIVDDOn the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06970291983426
Basic UDI-DI: B-06970291983426
Reference: JZ411TY
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST Control(L)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024099
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023932-00
EMDN: W0102152211
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST Control(H)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024105
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023933-00
EMDN: W0102152211
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024112
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023903-00
EMDN: W0102152211
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST Control(H)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024129
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023925-00
EMDN: W0102152211
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST Control(L)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024136
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023924-00
EMDN: W0102152211
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

sCD14-ST (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024143
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023902-00
EMDN: W0102152211
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details