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Optiform Flex OF1AD

by Sigvaris, Inc.

Part of a family of 52 devices: see the family page

Ref OF1ADModel OPTIFORM FLEX

Optiform Flex OF1AD is a Class I device made by Sigvaris, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 7613378OPTIFLEXKW) and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 07613378093760), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7613378OPTIFLEXKW Basic UDI-DI 07613378093760UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613378093760 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7613378OPTIFLEXKW registered 21 May 2026 Active
  • FDA GUDID UDI-DI 07613378093760 listed 11 Nov 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 07613378093760
  2. Registered EUDAMED 7613378OPTIFLEXKW

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  • Withdrawn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
OF1AD, OPTIFORM FLEX
Primary DI / UDI-DI
07613378093760
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compression/pressure tubular garment

Similar devices in this category

Other devices filed under BANDAGES.

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 (20, all answered No)