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Optiform Hold OH3BG

by Sigvaris, Inc.

Part of a family of 104 devices: see the family page

Ref OH3BGModel OPTIFORM HOLD

Optiform Hold OH3BG is a Class I device made by Sigvaris, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 7613378OPTIHOLDL8) and listed in FDA GUDID since 12 Nov 2024 (UDI-DI 07613378092688), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7613378OPTIHOLDL8 Basic UDI-DI 07613378092688UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613378092688 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7613378OPTIHOLDL8 registered 21 May 2026 Active
  • FDA GUDID UDI-DI 07613378092688 listed 12 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 07613378092688
  2. Registered EUDAMED 7613378OPTIHOLDL8

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  • Withdrawn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 Hold
Generic name
Compression/pressure tubular garment
Model / Ref / Catalog
OH3BG, OPTIFORM HOLD
Primary DI / UDI-DI
07613378092688
Basic UDI-DI
7613378OPTIHOLDL8
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)