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Stealth Belt®

by Stealth Belt, Inc. 46 variants

Ref PR32-38RT214BLK, PR28-34LT214BLK-VR, PR24-30RT314BLK, PR36-42LT134BLK-VR, PR28-34LT134BLK, PR40-46RT234BLK, PR24-30RT134BLK-VR, PR24-30LT234BLK-VR, PR28-34LT314BLK, PR44-50RT234BLK, PR32-38LT314BLK-VR, PR32-38LT134BLK-VR, PR36-42RT134BLK-VR, PR36-42RT234BLK-VR, PR32-38LT214BLK, PR44-50LT214BLK, PR36-42RT214BLK, PR36-42LT214BLK-VR, PR36-42RT134BLK, PR40-46LT234BLK, PR44-50LT214BLK-VR, PR40-46RT234BLK-VR, PR40-46LT214BLK, PR40-46LT314BLK-VR, PR44-50LT314BLK, PR24-30LT314BLK, PR32-38RT234BLK, PR40-46RT214BLK, PR24-30RT314BLK-VR, PR40-46LT234BLK-VR, PR44-50RT214BLK-VR, PR40-46RT134BLK-VR, PR40-46RT314BLK, PR40-46RT214BLK-VR, PR44-50LT234BLK, PR40-46LT314BLK, PR44-50LT134BLK-VR, PR28-34RT234BLK, PR28-34RT314BLK-VR, PR28-34LT134BLK-VR, PR24-30RT214BLK, PR24-30RT214BLK-VR, PR28-34RT134BLK, PR28-34RT214BLK-VR, PR32-38RT214BLK-VR, PR24-30RT234BLK-VR, PR28-34LT314BLK-VR, PR40-46RT134BLK, PR44-50RT314BLK-VR, PR44-50RT234BLK-VR, PR24-30LT214BLK

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506091772AA003M Basic UDI-DI Date7 Nov 2022RegisteredStatusActive

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  • Withdrawn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
Stealth Belt®
Model / Reference
PR32-38RT214BLK, PR28-34LT214BLK-VR, PR24-30RT314BLK, PR36-42LT134BLK-VR, PR28-34LT134BLK, PR40-46RT234BLK, PR24-30RT134BLK-VR, PR24-30LT234BLK-VR, PR28-34LT314BLK, PR44-50RT234BLK, PR32-38LT314BLK-VR, PR32-38LT134BLK-VR, PR36-42RT134BLK-VR, PR36-42RT234BLK-VR, PR32-38LT214BLK, PR44-50LT214BLK, PR36-42RT214BLK, PR36-42LT214BLK-VR, PR36-42RT134BLK, PR40-46LT234BLK, PR44-50LT214BLK-VR, PR40-46RT234BLK-VR, PR40-46LT214BLK, PR40-46LT314BLK-VR, PR44-50LT314BLK, PR24-30LT314BLK, PR32-38RT234BLK, PR40-46RT214BLK, PR24-30RT314BLK-VR, PR40-46LT234BLK-VR, PR44-50RT214BLK-VR, PR40-46RT134BLK-VR, PR40-46RT314BLK, PR40-46RT214BLK-VR, PR44-50LT234BLK, PR40-46LT314BLK, PR44-50LT134BLK-VR, PR28-34RT234BLK, PR28-34RT314BLK-VR, PR28-34LT134BLK-VR, PR24-30RT214BLK, PR24-30RT214BLK-VR, PR28-34RT134BLK, PR28-34RT214BLK-VR, PR32-38RT214BLK-VR, PR24-30RT234BLK-VR, PR28-34LT314BLK-VR, PR40-46RT134BLK, PR44-50RT314BLK-VR, PR44-50RT234BLK-VR, PR24-30LT214BLK
Primary DI / UDI-DI
05060917725330, 05060917725699, 05060917725194, 05060917725842, 05060917725200, 05060917725507, 05060917725644, 05060917725620, 05060917725231, 05060917725583, 05060917725798, 05060917725767, 05060917725880, 05060917725903, 05060917725293, 05060917725538, 05060917725415, 05060917725859, 05060917725408, 05060917725460, 05060917726016, 05060917725989, 05060917725453, 05060917725958, 05060917725552, 05060917725156, 05060917725347, 05060917725491, 05060917725675, 05060917725941, 05060917726054, 05060917725965, 05060917725514, 05060917725972, 05060917725545, 05060917725477, 05060917726009, 05060917725262, 05060917725750, 05060917725682, 05060917725170, 05060917725651, 05060917725248, 05060917725736, 05060917725811, 05060917725668, 05060917725712, 05060917725484, 05060917726078, 05060917726061, 05060917725132
Basic UDI-DI
506091772AA003M
EMDN Code
A108006 Abdominal ostomy support belts
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000028364
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Stealth Belt, Inc.

See all devices from Stealth Belt, Inc. →

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