Quality and manufacturing
RK Group coronary stents and balloon catheters are made and sterilised at our plant in Grozny. This page gathers what documents confirm: registration, the production inspection, the standards applied, sterilisation and storage.
Quality management system
On 19–22 August 2024 the RK Group plant passed an inspection by VNIIIMT, the Roszdravnadzor institute for medical devices of how its quality management system for medical devices is implemented, maintained and assessed according to the potential risk of their use.
Since 1 January 2024, new medical devices cannot be registered, and registered ones cannot be changed, without a positive conclusion from such an inspection.
Registration and technical specifications
| Device | Registration certificate | Technical specification (TU) |
|---|---|---|
| PUT NIY | РЗН 2020/12264 dated 09.10.2020 | — |
| R-Stent | РЗН 2025/25737 dated 30.06.2025 | TU 32.50.22-007-28604018-2024 |
| NASH+ | РЗН 2025/25736 dated 24.06.2025 | TU 32.50.22-006-28604018-2024 |
| RAMA | РЗН 2021/13781 | TU 32.50.13-002-28604018-2019 |
| NC RAMA | РЗН 2021/13781 | TU 32.50.13-002-28604018-2019 |
Sterilisation, storage, shelf life
| Devices | Sterilisation | Storage | Shelf life |
|---|---|---|---|
| R-Stent, NASH+ | Ethylene oxide (gas sterilisation) | +15 °C to +30 °C, humidity up to 60%, in the original packaging | 24 months from sterilisation |
| RAMA, NC RAMA | Ethylene oxide (gas sterilisation) | 0 °C to +40 °C, humidity up to 60%, in the original packaging | 36 months from sterilisation |
From the instructions for use. Re-sterilisation is not allowed.
Standards applied
Devices
- GOST R ISO 25539-2-2012Cardiovascular implants. Endovascular devices. Part 2: Vascular stents (ISO 25539-2)
- GOST R ISO 14630-2017Non-active surgical implants. General requirements (ISO 14630)
- GOST ISO 10555-1-2021Intravascular catheters, sterile, single-use. Part 1: General requirements (ISO 10555-1)
- GOST ISO 10555-4-2022Intravascular catheters, sterile, single-use. Part 4: Balloon dilatation catheters (ISO 10555-4)
- GOST R ISO 80369-7-2023Small-bore connectors for liquids and gases. Part 7: Intravascular or hypodermic applications (ISO 80369-7)
- GOST 20790-93Medical instruments, apparatus and equipment. General specifications
Biological safety
- GOST R 52770-2023Medical devices. Biological evaluation system. General safety requirements
Sterilisation and packaging
- GOST ISO 11135-2017Sterilisation of health-care products. Ethylene oxide. Development, validation and routine control (ISO 11135)
- GOST ISO 11607-1-2018Packaging for terminally sterilised medical devices. Part 1: Materials and packaging systems (ISO 11607-1)
- GOST ISO 11607-2-2018Packaging for terminally sterilised medical devices. Part 2: Validation of processes (ISO 11607-2)
Labelling
- GOST R ISO 15223-1-2023Medical devices. Symbols to be used with information supplied by the manufacturer (ISO 15223-1)
The main applicable standards as listed in the instructions for use.
Quality feedback
Report any product nonconformity through the complaint form, with the lot number and, if available, the procedure report. Our quality specialist will contact you.
Production address: Kemerovskaya st. 12, Baysangurovsky district, Grozny, Chechen Republic, 364047, Russia