Zimmer Orthopedics Manufacturing Limited
Pianta certificata dall'ente regolatore sanitario brasiliano (ANVISA)
ANVISA, l'ente regolatore sanitario brasiliano, detiene un certificato di buona pratica di fabbricazione valido per questo impianto, che copre i dispositivi medici (programma di audit MDSAP), valido fino al 20/01/2029. Il certificato viene rilasciato dopo un'ispezione dello stabilimento stesso, motivo per cui un regolatore straniero nomina questo sito: le merci prodotte qui sono ammesse sul mercato brasiliano. Il certificato registra l'indirizzo del sito come: BUILDING 2, EAST PARK, SHANNON INDUSTRIAL ESTATE, SHANNON, CO. CLARE, V14 WN80. Numero processo 25351346024201891.
- Type
- brand seeking distribution
- Location
- Shannon, Ireland
- Categories
- Forniture medicali e sanitarie
- Markets
- Irlanda, Brasile
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- debarment-clear (green), checked 2026-09-02 OpenSanctions
- fda-registered (green), checked 2026-09-02 FDA
- fda-contract-manufacturer (green), checked 2026-09-02 FDA
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
- listed-in-registry (green), checked 2026-09-02 BRIS, EU business registers interconnection (e-justice.europa.eu)
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
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)