J. Mitra & Co. Pvt. Ltd.
Manufactures rapid diagnostic test kits for HIV, malaria, dengue, hepatitis, and tuberculosis.
Manufactures rapid diagnostic test kits for HIV, malaria, dengue, hepatitis, and tuberculosis. A WHO-prequalified manufacturer supplying to national health programs and NGOs in over 60 countries.
- Type
- Manufacturer
- Location
- New Delhi, India
- Founded
- 1968
- Website
- jmitra.co.in
- Categories
- Medical & Healthcare Supplies
- Markets
- India, Nigeria, Kenya, Ethiopia, Tanzania
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- export-registered (green), checked 2026-08-21 Pharmexcil member directory (Pharmaceuticals Export Promotion Council of India, Ministry of Commerce)
- registered-manufacturer (green), checked 2026-08-21 Pharmexcil member directory (Pharmaceuticals Export Promotion Council of India, Ministry of Commerce)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)