FDA.reportPublic FDA data

ONWARD Medical N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30342114473034211447ONWARD Medical N.V.1N2026-01-01Schimmelt 2 Eindhoven Noord-Brabant NL 5611 ZX

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08720908310002ARC-EX System - ARC-EX System - Professional US+1 (617) 488 8642support@onwd.com
08720908310002ARC-EX System - ARC-EX System - Professional US+1 (866) 217 0817support@onwd.com
08720908310033ARC-EX System - ARC-EX System - Personal US+1 (866) 217 0817support@onwd.com
08720908310033ARC-EX System - ARC-EX System - Personal US+1 (617) 488 8642support@onwd.com
08720908310040ARC-EX System - ARC-EX System - Professional US+1 (866) 217 0817support@onwd.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3340991853497091K251821ARC-EX SystemSDO2025-11-14
3340991485845398DEN240014ARC-EX SystemSDO2024-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SDO22025-11-14

GUDID#