Manufacturer

Cdrsys

CanadaLegal entities : CDR Systems Inc.

Markets : France · United States

Approvals : EU – class I · United States (FDA) – 510(k) : 1 · class II · latest in 2013 · see on the FDA website

EU representative : Advena Limited (Malta)

1 category, 30 models including 30 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Patient positioning instruments - hardware accessories	Z12011280	BB09 Belly Board Series3 refs BM02-T EXT-24STD ExtremityLock Series3 refs Freedom Compression Belt Series3 refs FreedomX / Equilibrium / SaBella Flex Series 25 others FreedomX Comprehensive Overlay Series3 refs FreedomX MR Conditional Comprehensive Overlay Series IB06 Indexing Bar Series3 refs IB06 MR Safe Indexing Bar Series Instaform Kit Series2 refs LB02 LB02-K LT-Thermoplastic™ Series3 refs PB06 Prone Breast Positioning Series PB17 MR Conditional ProCline Series PB17 ProCline Series3 refs PH08 MR Conditional Prone Head & Neck Series PH08 Prone Head & Neck Series PLUS-01 Positioning Aid Series3 refs SB-HP Hand Indexer Series SB02 SB02-S1 SB02-ST SBS14 MR Conditional SaBella Flex Series SBS14 SaBella Flex Series3 refs Solid Bolus Series3 refs THS03 Head Support Series3 refs TP01F Table Pad Series Vacuum Lock Cushion Series3 refs	I MDR	EUDAMED record Report an error

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