Agappe Diagnostics Ltd.
Производит клинические химические анализаторы, гематологические анализаторы, средства быстрой диагностики и реагенты…
Производит клинические химические анализаторы, гематологические анализаторы, средства быстрой диагностики и реагенты для клинических лабораторий. Обслуживает больницы, банки крови и диагностические центры по всей Индии и более чем на 50 экспортных рынках.
- Type
- brand seeking distribution
- Location
- Ernakulam, India
- Founded
- 1992
- Website
- agappe.com
- Categories
- Медицинские товары и расходники
- Markets
- Индия, ОАЭ, Нигерия, Кения, Вьетнам
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)