6 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Italy
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BTS S.p.A.
Manufacturer
🇮🇹 Italy
BTS SPA
FDA registration
BTS SPA·4 products·🇮🇹 Italy
2TS s.r.l.
Manufacturer
🇮🇹 Italy
PUNTALE GOMMA COLORE GRIGIO DIAM.MM.14 PER QUADRIPODE B.S.
Device
EU MDR
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Eu Md Class 1
·PRAXIS MEDICAL NETWORK SRL·On the market
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Enforcement
Class II
·Ongoing·EMPATICA SRL·November 1, 2023
BTL ITALIA S.r.l.
Authorized representative
🇮🇹 Italy·1 Manufacturer