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06.07.2026 20:24

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135 device results listed.

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Total Laboratory Automation

LS 10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028504655
Basic UDI-DI: 697052264YQ05KP
Reference: QD1001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

S100 Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028503092
Basic UDI-DI: B-06942028503092
Reference: DI0101
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

Myeloperoxidase(MPO) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028503009
Basic UDI-DI: B-06942028503009
Reference: CA3101
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502606
Basic UDI-DI: B-06942028502606
Reference: DD2101
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-trophoblast cell membrane antibody(TA-Ab) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502569
Basic UDI-DI: B-06942028502569
Reference: DB2201
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Reverse Triiodothyronine (rT3) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502521
Basic UDI-DI: B-06942028502521
Reference: CL2301
EMDN: W01020404
EMDN description: REVERSE TRIIODOTHYRONINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Alkaline Phosphatase (BAP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502484
Basic UDI-DI: B-06942028502484
Reference: DH0401
EMDN: W0102060318
EMDN description: BONE ALKALINE PHOSPHATASE (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502446
Basic UDI-DI: B-06942028502446
Reference: DH0301
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Gla Protein (BGP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502408
Basic UDI-DI: B-06942028502408
Reference: DH0201
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

β-Crosslaps(β-CTx) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502361
Basic UDI-DI: B-06942028502361
Reference: DH0101
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502286
Basic UDI-DI: B-06942028502286
Reference: DF1101
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-beta 2 Glycoprotein 1 Antibody IgA/G/M (β2-GP1-IgA/G/M) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502200
Basic UDI-DI: B-06942028502200
Reference: DB2001
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cardiolipin antibody IgA/G/M (aCL-A/G/M) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502040
Basic UDI-DI: B-06942028502040
Reference: DB1601
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Human Chorionic Gonadotropin antibody (HCG-Ab) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501968
Basic UDI-DI: B-06942028501968
Reference: DB1401
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgM(ZP-IgM) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501920
Basic UDI-DI: B-06942028501920
Reference: DB1301
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-zona pellucida antibody IgG(ZP-IgG) Detection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501883
Basic UDI-DI: B-06942028501883
Reference: DB1201
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Folic Acid (FA) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501845
Basic UDI-DI: B-06942028501845
Reference: CJ0301
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501807
Basic UDI-DI: B-06942028501807
Reference: CJ0201
EMDN: W0102070301
EMDN description: VITAMIN B 12 / FOLATE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

IgG4 Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501760
Basic UDI-DI: B-06942028501760
Reference: DB2101
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

t-PAIC Assay Kit(Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501722
Basic UDI-DI: B-06942028501722
Reference: DG0301
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details