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Built on Clinical Knowledge. Delivered with Precision.
Who We Are
Ivannka Medical Systems is an Indian manufacturer and authorised supplier of diagnostic X-ray systems, radiation protection equipment, and digital radiography technology. We exist to serve the clinical professionals and healthcare institutions that depend on imaging equipment being exactly right: consistent, compliant, and supported.
We manufacture X-ray systems, lead aprons, and X-ray view boxes at our facility in Sector 63, Noida, India. We supply flat panel detectors, lead glass panels, and lead sheets as an authorised channel partner for global manufacturers. Our clients include government teaching hospitals, large private hospital groups, diagnostic networks, and specialist clinical facilities across India.
Our Manufacturing Facility
MANUFACTURING ADDRESS
F 386, Sector 63, Noida, Uttar Pradesh, India
MANUFACTURING SCOPE
In-house design, assembly, and quality testing of diagnostic X-ray systems, lead aprons, and X-ray view boxes. Component traceability maintained under ISO 13485 quality management standards.
Location
Sector 63, Noida
Uttar Pradesh, India
Products Manufactured
X-Ray Machines, Lead Aprons, LED X-ray View Boxes/ Illuminator/ Lobby
Quality Standard
Quality Management System:- ISO 9001:2015
MD Quality Management System:- ISO 13485:2016
Regulatory Licence
MD-09 Manufacturing Licence under MDR 2017, BIS, AERB, CDSCO, NABL
Traceability
Traceability Full component and batch traceability maintained
Our Regulatory Standing
Every product we manufacture or supply is specified, documented, and supported within the framework of India’s applicable medical device and radiation safety regulations. We do not compromise on compliance, and we support our clients in maintaining their own facility compliance documentation.
| Certification | Certification Issued By / Standard | Status |
|---|---|---|
|
Class C & D Medical Device
|
CDSCO, MDR 2017 |
Certified |
|
BIS Certification |
Bureau of Indian Standards |
Certified |
|
ISI Mark |
Bureau of Indian Standards |
Certified |
|
ZED Certification |
Ministry of MSME, Govt. of India |
Certified |
|
BARC Approval |
Bhabha Atomic Research Centre |
Certified |
|
ISO 13485:2016 |
Medical Device Quality Management System |
Certified |
|
ISO 9001:2015 |
Quality Management System |
Certified |
|
AERB Approval |
Atomic Energy Regulatory Board |
Certified |
|
CDSCO Registration |
Central Drugs Standard Control Organisation |
Certified |
|
MD-09 Licence |
Manufacturing license Under Class – C & D |
Certified |
Our Supply Reach
Ivannka Medical Systems supplies to clinical institutions across India. We are also positioned to supply to international markets. For international enquiries, please contact our team directly.