Hero Arm

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Open Bionics Ltd.·1 device

HL 2110160-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Bionime Corporation·TÜV Rheinland LGA Products GmbH·36 Basic UDI-DIs

21M00054CRT02

Certificate

MDR QMS·Reboocon Bionics B.V.·Kiwa Dare B.V.

IT266961

Certificate

MDD Annex V·TEHNO BIONIC SRL·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI

Bionic Medizintechnik GmbH

Importer

🇩🇪 Germany

BIONIC IBERICA, S.A.

Importer

🇪🇸 Spain·1 Manufacturer

Advanced Bionics GmbH

Importer

🇩🇪 Germany·1 Manufacturer

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon

Bionime Corporation

System producer

🇹🇼 Taiwan

Diamedics, s.r.o.

Importer

🇨🇿 Czechia·1 Manufacturer

HUNGIMPEX Kft.

Importer

🇭🇺 Hungary·1 Manufacturer

KARABINIS MEDICAL S.A.

Importer

1 Manufacturer

ILINE MICROSYSTEMS S.L.

Importer

🇪🇸 Spain·1 Manufacturer

Salvus društvo s ograničenom odgovornošću za trgovinu i usluge

Importer

🇭🇷 Croatia·1 Manufacturer

BIOSEVEN SRL

Importer

🇮🇹 Italy·1 Manufacturer

STADAPHARM GmbH

Importer

🇩🇪 Germany·1 Manufacturer

BIOSEVEN SRL

Authorized representative

🇮🇹 Italy·1 Manufacturer·39 Devices

Ypsomed Distribution GmbH

Importer

🇩🇪 Germany·2 Manufacturers

Advanced Bionics GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Bionic Power Italy S.r.l.

Authorized representative

🇮🇹 Italy·1 Manufacturer