More information on REDA Instrumente ISO / CE / FDA certification

All products manufactured by REDA Instrumente GmbH are CE certified by the manufacturer in accordance with strict European health and safety regulations (93/42/EEC), assuring product quality and patient safety to customers within Europe and beyond. The relevant CE-certificate is available for download here.

In addition, most products are also guaranteed by the manufacturer to have USA FDA approval and to have been manufacturered in accordance with ISO 13485 standards. In addition, with regard of (humane) use in USA only, customers who have their own 510(k) certification may be able to import any product from the REDA portfolio (please contact us for any details).

Through upholding these quality standards, REDA Instruments usually come with a limited manufacturer's warranty of up to 5 years on selected products (REDA Instrumente GmbH Terms & Conditions apply).

Should there be any specific information required regarding manufacturer's warranty and certification with regard to any particular country, please contact us in advance before ordering.

REDA Instrumente GmbH Corporate Profile REDA Instrumente GmbH was founded in 1990 in Tuttlingen (Germany), with a combined in-house experience of more than 100 years.

REDA has a first class quality management system, built upon FDA regulations. DIN EN ISO 13485:2003, DIN ISO 9001 and DIN EN 46001 certificates, as well as EEC 93/42 authorize REDA to manufacture their instruments with the valued CE mark, for which the requirements are usually more stringent than the FDA requirements.

REDA is able to offer a complete range of surgical instruments covering all types of surgery, including:

Open Surgery
Neuro Surgery
Dental
Rigid Endoscopy:
- Laparascopy
- Pelviscopy
- Arthroscopy
- Gynaecology
- Urology
- ENT
Flexible Endoscopy, accessories for flexible endoscopy

REDA Instrumente GmbH strives to offer first class products, manufactured by highly trained precision engineers using most up to date C & C machines.

This is also reflected in the 5 year manufacturer's warranty that applies to many REDA instruments:

"Our REDA products are free from manufacturing defects in material and workmanship. We therefore give on all general surgical instruments a guarantee of five years provided that the instruments are maintained and cleaned properly and used normally for their intended purpose."


© 1999-2024 Mitracom @ www.hospital-products.com [software & content].

Your IP address:	Today's date: Wednesday Sep 18, 2024 @ 1:29 PM CET	Page processing time: 0.2336 seconds