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Optiform Flex OF2B1D

by Sigvaris, Inc.

Ref OF2B1DModel OPTIFORM FLEX

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7613378OPTIFLEXKW Basic UDI-DI 07613378093470UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613378093470 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Optiform Flex
Generic Name
Compression/pressure tubular garment
Model / Ref / Catalog
OF2B1D, OPTIFORM FLEX
Primary DI / UDI-DI
07613378093470
Basic UDI-DI
7613378OPTIFLEXKW
FDA Product Code
FQL
EMDN Code
M030405 Compression stockings
GMDN Term
Compression/pressure tubular garment
Device Class
Class I
Regulation Number
880.5780
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compression/pressure tubular garment

Other devices from Sigvaris, Inc.

See all devices from Sigvaris, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No