WE ARE
CERTIFIED
Safety and quality are non-negotiable in the medical devices industry. With the stringent regulatory requirements and specialized medical standard certifications, PROMED stresses the high quality standards, and their performance for our customers and partners.
WE ARE
INNOVATIVE
In an ever-changing environment of technology and culture, PROMED stays ahead by constantly changing and adapting ourselves. We maintain an open mind to grow, understand the needs and create competitive quality products.
WE MANUFACTURE
QUALITY PRODUCTS
We place great importance on product quality and durability from development stage. We perform comprehensive quality and functionality checks of all products and production cycles. Doing all these, we make sure our products meet all relevant international standards and regulations.
General Surgery
• Disposable & Reusable Electrosurgical Pencil
• Disposable Electrode, High Insulation
• Disposable LLETZ / LEEP Electrode
• Reusable Bipolar Forceps
• Disposable Ground Pad and Cable
• Disposable Smoke Evacuation Pen
Precision Surgery
HOT: Aesthetic, Plastic & Comestic Surgeries
– Perfect for Eyelid lift Brow lift Face lift Rhinoplasty
• Microfin Compact Electrosurgical Pencil
• Microfin Bendable Gold Electrode
• Microfin Ultra Sharp Microdissection Needle
Less bleeding, less scar, less smoke, shorter recovery period
Arthroscopy
• Disposable Arthroscopic Electrode
Laparoscopy
• Disposable Laparoscopic Electrode
• Disposable Laparoscopic Instrument
• Disposable Suction Irrigator
Wound Closure
• Disposable Skin Stapler
• Disposable Staple Remover
Personal Protective Equipment
• Surgical Mask
• Surgical Isolation Gown
PROMED represents a dedicated team of Medical Professionals, including experts in Research & Development, Product Marketing, Quality & Regulatory, Production and Corporate Management. We pursue and maintain the goal of excellence.
PROMED is your trustworthy and reliable partner in the high demanding medical market. Today, PROMED continues to fulfil market demand with innovative products in a reliable and cost-effective manner.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard. We can proudly and safely state that PROMED products are built with quality and transparency in mind to provide products that meet or exceed the needs and expectations of our customers, and always complying with the specifications and regulations.
The Medical Device Single Audit Program (MDSAP) is a harmonized approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale that will cover and their respective regulatory requirements. The current program participants include: USA, Canada, Australia, Japan and Brazil.
THE MEDICAL DEVICES DIRECTIVE, CE MARKING FOR EUROPE
Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC. PROMED has acquired this certification and our products are eligible to be marketed in Europe.
This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. PROMED products are cleared under FDA 510(k) requirement and are also qualified and marketable in the United States.