Skip to content

OraStretch® Press Device w/ Power Bands – Pediatric

by CranioMandibular Rehab, Inc.

Ref CR1025

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 Number0850056079CR10SV Basic UDI-DI 00850056079365UDI-DIDate22 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  • Withdrawn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

Device Name
OraStretch System
Model / Reference
CR1025
Primary DI / UDI-DI
00850056079365
Basic UDI-DI
0850056079CR10SV
Direct Marketing DI
00850056079365
EMDN Code
Z120602 Physiotherapy equipment
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000039893
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from CranioMandibular Rehab, Inc.

See all devices from CranioMandibular Rehab, 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