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IMAK Compression A20130

by Brownmed, Inc.

Ref A20130Model Small

IMAK Compression A20130 is a Class I device made by Brownmed, Inc., registered in EUDAMED on 14 May 2026 (Basic UDI-DI 649833IMAKCAWDE) and listed in FDA GUDID since 26 Aug 2020 (UDI-DI 06498332013098), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number649833IMAKCAWDE Basic UDI-DI 06498332013098UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06498332013098 UDI-DI Date26 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 649833IMAKCAWDE registered 14 May 2026 Active
  • FDA GUDID UDI-DI 06498332013098 listed 26 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06498332013098
  2. Registered EUDAMED 649833IMAKCAWDE

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  • Withdrawn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
IMAK® Compression EUDAMED
IMAK Compression GUDID
Generic name
Wrist orthosis
Device name
IMAK® Compression Arthritis Wrist
Model / reference
A20130, Small
Primary DI / UDI-DI
06498332013098 EUDAMED
00649833201309 GUDID
Basic UDI-DI
649833IMAKCAWDE
FDA product code
ILH
EMDN code
M0304010101 Elastic compression bandages, non-adhesive, low extensibility (<70%)
GMDN term
Wrist orthosis
Device class
Class I
Regulation number
890.3475
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06498332013098
GUDID
00649833201309

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06498332013098; FDA GUDID lists 00649833201309), so their flags are not compared.

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Properties

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