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Essential THERMOREGULATING

by Sigvaris AG 1,000+ variants

Ref 320732Model Essential THERMOREGULATING

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 23 Oct 2026. What this means

Overview

The Essential THERMOREGULATING device is a medical device designed to control temperature, providing comfort and relief for individuals with certain endocrine disorders. This device features a sterile design, ensuring the highest level of sterility and safety. With its simple and intuitive interface, users can easily monitor and adjust the device's settings to achieve optimal results.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611711ETHDN Basic UDI-DI 07613378194863UDI-DIDate20 May 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  • Withdrawn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

Model / Reference
Essential THERMOREGULATING, 320732
Primary DI / UDI-DI
07613378194863
Basic UDI-DI
7611711ETHDN
EMDN Code
M030405 Compression stockings
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000015565
Authorised representative
Sigvaris GmbH DE-AR-000010016

Related devices

Category: Compression/pressure sock/stocking, single-use

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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