The main objective of GENKO MED GROUP company is to produce and sell medical devices in accordance with technical specifications, the requirements of national and international standards and regulations that fully satisfy the customers’ needs and expectations.
The quality and optimal cost of GENKO products has always been our staff’s concern.
The medical devices manufactured at GENKO MED GROUP are in accordance to the following standards:
• ISO 7886-1: 2003 - Sterile hypodermic syringes for single use
- Part 1: Syringes for manual use;
•SR EN ISO 7864:2004 - Sterile hypodermic needles for single use;
•SR EN ISO 8537/A1: 2002 - Sterile insulin syringes for single use, with or without needle.
• Romanian Pharmacopoeia, ed. X and Supplement 2000
• European Pharmacopoeia (EP):
- Sutures monograph for human use - sterile , synthetic absorbable, braided sutures
- Sutures monograph for human use - sterile, synthetic, absorbable, monofilament sutures
- Sutures monograph for human use - sterile non- absorbable sutures
• American Pharmacopoeia (USP):- Monograph - absorbable and non- absorbable sutures
• EN ISO 10993-1:2003 -Biological evaluation of medical devices; Evaluation and testing
The medical devices made by MED GROUP GENKO are in accordance with the requirements of Directive 93/42/EEC (GD 54:2009) and bear the mark CE1868 .
MED GROUP GENKO company holds the following certificates:
Product Certificates:
- EC type-examination Certificate No. 3 DM 3 for sterile suture materials , non absorbable and absorbable, with / without needle, issued by OTDM - Certification Bucharest (see certificate here).
- Production quality assurance Certificate EC-No. 3 DM 5 for sterile hypodermic syringes and needles of single use, sterile syringes for insulin U - 40/100 of single use , and sterile non absorbable and absorbable suture materials of single use, issued by OTDM - Certification Bucharest (see certificate here).
System Certificate:
- ISO Certificate 13485- No.3 SMC1 - issued by OTDM - Bucharest certifying that GENKO MED GROUP has established and maintains a Quality Management System that meets SR EN ISO standards 13485:2004, SR EN ISO 13485:2004 / AC: 2010 (see certificate here)
- Certificate of the Management System according to EN ISO 9001:2008, No-731002241 issued by TUV PROFI CERT by TUV Hessen Germany (see certificate here).