Manufacturer

Sichuan Orienter Biotechnology

ChinaLegal entities : Sichuan Orienter Biotechnology Co., Ltd.

Markets : Germany · Italy · Netherlands · Spain

Approvals : EU – class A

EU representative : Medunion S.L. (Spain)

Website info@orienterglobal.com

22 categories, 38 models including 38 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
IVD general use consumable devices - other	W0599	Access Substrate 130mL×4 Chemiluminescence Reaction Vessel 1000 PCS *8 packs/box Daily Maintenance Solution 35mL×2 Disposable Sample Cups 1000 pieces/bag of 0.5mL Fecal Staining Solution 100 mL/bottle 3 others Sample Probe Wash Buffer 2.5L×2 System Check Solution 10mL×4 Wash Buffer 10L	A IVDR	EUDAMED record Report an error
Other interleukins (except for il-6)	W01030606	Interleukin -10 (IL-10) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Interleukin -17A (IL-17A) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interleukin -4 (IL-4) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interleukin -8 (IL-8) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79 Interleukin-1β (IL-1β) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79	– 98/79	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	Concentrated Cleaning Fluid 10 mL/tube1, 10 mL/tube 2, 10 mL/tube5, 10 mL/tube10, 10 mL/bottle, 50 mL/bottle, 100 mL/bottle, 200 mL/bottle, 500 mL/bottle Flushing Fluid 5L/barrel、10L/barrel、15L/barrel、20L/barrel、25L/barrel Sample Diluent 1.6mL/tube×25, 1.6mL/tube×50, 1.6mL/tube×100, 2.8L/barrel, 5L/barrel, 10L/barrel, 20L/barrel, 2.8L/barrel ×2, 5L/barrel ×2	A IVDR	EUDAMED record Report an error
Interferons (α, β, ɣ…)	W01030601	Interferon Alpha (IFNα) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Interferon Gamma (IFNγ) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Other haemoglobin (types) testing - other	W0103010299	Fecal Occult Blood (FOB) Test Kit (Colloidal Gold) Cassette type: 100 pcs/box98/79 Fecal Occult Blood (FOB) Test Kit (Colloidal Gold) Cassette type: 50 pcs/box98/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Blood Collection System IS 10 Total Laboratory Automation LS 10	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - high routine (throughput > 700 test/h)	W0201020104	Automatic Chemistry Analyzer CA2000	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automatic Chemiluminescence Immunoassay Analyzer LA 2000	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	Automatic Chemiluminescence Immunoassay Analyzer LA 3000	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Pneumatic Tube System ST10	A IVDR	EUDAMED record Report an error
Coagulation inhibitors - other	W0103020699	Thrombomodulin (TM) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer (D-D) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Faeces collection devices	W05019001	Sample Collection Tube 400 Branch/Box	A IVDR	EUDAMED record Report an error
Feces and urine collection aids (bed pans and parrots)	V0812	Fully Automatic Digital Feces Analyzer FA 280	A IVDR	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) /2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...)	W01030607	Interleukin-2 Receptor (IL-2R) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79	– 98/79	EUDAMED record Report an error
Special coagulation tests - other	W0103020399	PIC Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay)	W0105010704	Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay) 16 Serving/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Thrombin-Antithrombin Ⅲ complex(TAT) Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Tissue plasminogen activator	W0103020507	t-PAIC Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) 2×50 test/box Calibrator:0.5mL×298/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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