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Steady Step 50164

by Brownmed, Inc.

Ref 50164Model X-Large-Gel & Magnets

Steady Step 50164 is a Class I device made by Brownmed, Inc., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 082161STSTHHWMXLGGFY) and listed in FDA GUDID since 17 Aug 2020 (UDI-DI 00082161501640), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number082161STSTHHWMXLGGFY Basic UDI-DI 00082161501640UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00082161501640 UDI-DI Date17 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 082161STSTHHWMXLGGFY registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI 00082161501640 listed 17 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00082161501640
  2. Registered EUDAMED 082161STSTHHWMXLGGFY

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  • Withdrawn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
HEEL HUGGER™ with Magnets EUDAMED
Steady Step GUDID
Generic name
Heel protector
Model / reference
50164, X-Large-Gel & Magnets
Primary DI / UDI-DI
00082161501640
Basic UDI-DI
082161STSTHHWMXLGGFY
FDA product code
ITW
EMDN code
M0304010101 Elastic compression bandages, non-adhesive, low extensibility (<70%)
GMDN term
Heel protector
Device class
Class I
Regulation number
890.3475
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Heel protector

Similar devices in this category

Other devices filed under BANDAGES.

Other devices from Brownmed, Inc.

See all devices from Brownmed, Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)