Agappe Diagnostics Ltd.
Manufactures clinical chemistry analyzers, hematology analyzers, rapid diagnostics, and reagents…
Manufactures clinical chemistry analyzers, hematology analyzers, rapid diagnostics, and reagents for clinical laboratories. Serves hospitals, blood banks, and diagnostic centers across India and 50+ export markets.
- Type
- Manufacturer
- Location
- Ernakulam, India
- Founded
- 1992
- Website
- agappe.com
- Categories
- Medical & Healthcare Supplies
- Markets
- India, United Arab Emirates, Nigeria, Kenya, Vietnam
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- domain-registered (green), checked 2026-08-03 Domain registry record
- 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)
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
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)