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Plaze

by Healthwell Medical, Inc. 2 variants

Ref H100 L MNL 5 01 3 ENModel HPS-100

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8800074100048W3 Basic UDI-DI D-8800074100048W3UDI-DIDate24 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
HPS-100, H100 L MNL 5 01 3 EN
Primary DI / UDI-DI
D-8800074100048W3
Basic UDI-DI
B-8800074100048W3
EMDN Code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000042051
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Healthwell Medical, Inc.

Properties

Other properties (11)

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