Agappe Diagnostics Ltd.
Fabrica analizadores de química clínica, analizadores de hematología, diagnóstico rápido y reactivos…
Fabrica analizadores de química clínica, analizadores de hematología, diagnóstico rápido y reactivos para laboratorios clínicos. Presta servicios a hospitales, bancos de sangre y centros de diagnóstico en toda la India y en más de 50 mercados de exportación.
- Type
- brand seeking distribution
- Location
- Ernakulam, India
- Founded
- 1992
- Website
- agappe.com
- Categories
- Suministros médicos y sanitarios
- Markets
- India, Emiratos Árabes Unidos, Nigeria, Kenia, 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
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- export-registered (green), checked 2026-08-21 Pharmexcil member directory (Pharmaceuticals Export Promotion Council of India, Ministry of Commerce)
- registry-activity (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)