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Perfect Fit 3D Effort Belt

by Dymedix Diagnostics, Inc. 2 variants

Ref 11-14001-2501Model Perfect Fit 3D

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08173770211450008M Basic UDI-DI 10817377020138UDI-DIDate3 Apr 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  • Withdrawn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

Model / Reference
Perfect Fit 3D, 11-14001-2501
Primary DI / UDI-DI
10817377020138
Basic UDI-DI
08173770211450008M
EMDN Code
Z12100585 Polysomnography instruments - consumables
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
US-MF-000015691
Authorised representative
MedEnvoy Global BV NL-AR-000024028

From the manufacturer

Manufacturer's product page: Respiratory Effort Belts

Other devices from Dymedix Diagnostics, Inc.

See all devices from Dymedix Diagnostics, 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