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ViVi® HELMET HPL

by THI Total Healthcare Innovation GmbH 2 variants

Ref 80130 Rev-S4Model ViVi® HELMET

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9009607HELMET80XXXHC Basic UDI-DI 09009607801349UDI-DIDate3 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ViVi® HELMET
Model / Reference
ViVi® HELMET, 80130 Rev-S4
Primary DI / UDI-DI
09009607801349
Basic UDI-DI
9009607HELMET80XXXHC
EMDN Code
L0316 Helmets and binocular glasses for surgeons
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
AT-MF-000044495

Other devices from Thi Total Healthcare Innovation GmbH

See all devices from Thi Total Healthcare Innovation GmbH →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No