UNIBELL SRL

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30074917513007491751UNIBELL SRL1N2026-01-01Via Indipendenza, 27 Calco Lecco IT 23885

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2294991294882736K181211Human Tecar HCR 1002PBX2018-09-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
PBX12018-09-10

GUDID

SUPERCHARGE HYDRA FASCIA ELECTRODES - Non-sterile commercial kit containing eight stimulation electrodes packaged together for convenience. The electrodes included in the kit are identical to devices marketed individually and are capacitive electrodes specific for the HCR1002 medical device: Structuranova / Ø 25 mm | sphere Structuranova / Ø 65 mm | thickness 25 mm Structuranova / Ø 90 mm | hickness 25 mm Lymphanova / oval Ømaj 20mm thickness 14mm Lymphanova / oval Ømaj 40mm thickness 14 mm Lymphanova / oval Ømaj 60mm thickness 14 mm Lymphanova / Ø 90 mm | ball Lymphanova / Ø 105 mm tickness 14 mm

UNIBELL SRL

2026-03-16

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