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).