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ViVi® PEEL-OFF HOOD

by THI Total Healthcare Innovation GmbH

Ref 80500V

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

14 Apr 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000302998 Date19 Feb 2026IssuedStatusActive expires 14 Apr 2030
United StatesGUDID listing GUDID Number09009607815001 UDI-DI Date10 Jun 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000302998 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    19 Feb 2026
    Expires
    14 Apr 2030
    Reason
    Add device or group

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical hood
Device Name
ViVi® GOWNS 80XXX
Model / Ref / Catalog
80500V
Primary DI / UDI-DI
09009607815001
Basic UDI-DI
9009607GOWNS80XXXD4
FDA Product Code
FXY
EMDN Code
T020401 Standard surgical gowns
GMDN Term
Surgical hood
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4040
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No