Essential CLASSICAL

by Sigvaris AG 1,000+ variants

Ref 28366

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

Overview

Essential CLASSICAL is a high-quality, FDA-cleared medical device designed to detect human endocrine disruptors. Developed by SIGVARIS AG, this instrument is ideal for professionals in the field of ophthalmology and otoaryngology who need accurate and reliable measurements.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number7611711ECLCB Basic UDI-DI 07611711283663UDI-DI	Date8 Apr 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: 28366

Primary DI / UDI-DI: 07611711283663
Basic UDI-DI: 7611711ECLCB
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

Other devices from Sigvaris AG

Style SEMITRANSPARENT

Class I
Essential CLASSICAL

Class I
Essential COMFORTABLE

Class I
Style PATTERN

Class I
Essential THERMOREGULATING

Class I
DELILAH 70 mesh / Tights Plus / Size 2 / closed / dune

Class I

See all devices from Sigvaris AG →

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