Medexel Medical Mfg. Co., Ltd.

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Contact: Daniel Kamm
Web: http://www.medexel.co.kr
E-Mail:
Address: 536-65 Kumkwang-Lee, Kumkwang-Myun, Ansung-Si 456 - 862, Korea, Republic Of
Phone: +82-(31)-677 8004 | Fax: +82-(31)-677 8007 | Map/Directions >>

Profile: Medexel Medical Mfg. Co., Ltd. is a producer and supplier of safety syringes. Our product line includes industrial blunt needles, plastic tapered needles and disposable safety syringes. Our disposable syringes and needles are sterilized by ethylene oxide gas.

The company is ISO 13488, ISO 9002, CE Mark certified.

FDA Registration Number: 3003589279
US Agent: Peter Chung / Plus Global
Phone: +1-(412)-512-8802 E-Mail:

8 Products/Services (Click for related suppliers)

• Antistick Syringe (FDA Code: MEG / 880.5860)

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.

• Endoscopic Prescription Lens Eyepiece (FDA Code: FDZ / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Liquid Medication Dispenser (FDA Code: KYX / 880.6430)

A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Piston Syringe (FDA Code: FMF / 880.5860)

• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200)

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Sterile Specimen Container (FDA Code: FMH / 864.3250)

A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.