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Atlante-Globe System

by Malvestio Spa 2 variants

Ref 378300, 318810, 318850, 318859Model 378350

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805830260SAGNBAF Basic UDI-DI 08058302603018UDI-DIDate18 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
378350, 378300, 318810, 318850, 318859
Primary DI / UDI-DI
08058302603018
Basic UDI-DI
805830260SAGNBAF
EMDN Code
V08060102, V080701, V0880
Device Class
Class I
Medical Purpose
The ATLANTE-GLOBE system is intended to assist the patient during his or her stay in the medical infrastructure and for the patient's prophylaxis and anti-decubitus therapy.

Manufacturer details

EUDAMED SRN
IT-PR-000046782

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Properties

Other properties (1)

  • Sterile: No