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377 device results listed.

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MAGLUMI Starter 1+2

Starter 1+2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145512675
Basic UDI-DI: 69471455302VS
Reference: 130299004M
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Wash Concentrate

Wash Concentrate

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145512644
Basic UDI-DI: 69471455303VU
Reference: 130299005M
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Microalbumin (Immunoturbidimetric)

Microalbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145511401
Basic UDI-DI: 69471455547WS
Reference: 130503004A
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Microalbumin (Immunoturbidimetric)

Microalbumin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145511364
Basic UDI-DI: 69471455547WS
Reference: 130503004S
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Transferrin (Immunoturbidimetric)

Transferrin (Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145509774
Basic UDI-DI: 69471455529WQ
Reference: 130508004A
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI TPA-snibe (CLIA)

TPA-snibe (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145506001
Basic UDI-DI: B-06947145506001
Reference: 130201007M
EMDN: W0102030117
EMDN description: TUMOR POLYPEPTIDE ANTIGEN (TPA - INCL. TPS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-SS-A IgG (CLIA)

Anti-SS-A IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505905
Basic UDI-DI: B-06947145505905
Reference: 130217013M
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-nRNP/Sm IgG (CLIA)

Anti-nRNP/Sm IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505868
Basic UDI-DI: B-06947145505868
Reference: 130217011M
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-M2-3E IgG (CLIA

Anti-M2-3E IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505806
Basic UDI-DI: B-06947145505806
Reference: 130217007M
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HAV IgM (CLIA)

HAV IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505516
Basic UDI-DI: B-06947145505516
Reference: 130210008M
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-HAV (CLIA)

Anti-HAV (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505493
Basic UDI-DI: B-06947145505493
Reference: 130210007M
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Chagas (CLIA)

Chagas (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505455
Basic UDI-DI: B-06947145505455
Reference: 130219001M
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Pepsinogen II (CLIA)

PG II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502195
Basic UDI-DI: B-06947145502195
Reference: 130201020M
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI PG I (CLIA)

PG I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502171
Basic UDI-DI: B-06947145502171
Reference: 130201019M
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI FK 506 (CLIA)

FK 506 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502157
Basic UDI-DI: B-06947145502157
Reference: 130207003M
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI A Ⅱ(CLIA)

A Ⅱ(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502133
Basic UDI-DI: B-06947145502133
Reference: 130206006M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI A Ⅰ(CLIA)

A Ⅰ(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145502119
Basic UDI-DI: B-06947145502119
Reference: 130206005M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI GAD65 (CLIA)

GAD65 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145501679
Basic UDI-DI: B-06947145501679
Reference: 130205005M
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Troponin I (CLIA)

Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145501495
Basic UDI-DI: B-06947145501495
Reference: 130206002M
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI CSA (CLIA)

CSA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145501457
Basic UDI-DI: B-06947145501457
Reference: 130207001M
EMDN: W0102080601
EMDN description: CYCLOSPORINE TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details