Bionime Corporation

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Contact: Alan Schwartz
Web: http://www.bionime.com
E-Mail:
Address: No. 694, Renhua Rd., Dali City, Taichung County 412, Taiwan
Phone: +886-(4)-2495-1268 | Fax: +886-(4)-2495-2568 | Map/Directions >>

Profile: Bionime Corporation is in the business of biotechnology and medical testing. Our first product line is the self monitoring blood glucose (SMBG) system. We operate in major markets, Europe, America and Asia. Our product range includes strip which adopts noble metal electrode and is designed well to prevent the blood sample from contamination. Our other products are GM550, GD500, GP300, GM550 and others.

The company was founded in 2003, has ~500 employees.

FDA Registration Number: 3004183148
US Agent: Feng-yu Lee / Dynamic Biotech Inc Dba Ivdd Regulatory Consultant
Phone: +1-(949)-218-0929 Fax: +1-(949)-218-2928 E-Mail:

4 Products/Services (Click for related suppliers)

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660)

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345)