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IMAK Ergo A30112

by Brownmed, Inc.

Ref A30112Model Universal

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number649833IMAKKHNBLT9 Basic UDI-DI 06498333011222UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06498333011222 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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® Ergo EUDAMED
IMAK Ergo GUDID
Generic Name
Musculoskeletal hot/cold therapy pack, reusable
Device Name
IMAK® Ergo HappiNeck - Blue
Model / Reference
A30112, Universal
Primary DI / UDI-DI
06498333011222 EUDAMED
00649833301122 GUDID
Basic UDI-DI
649833IMAKKHNBLT9
FDA Product Code
IQK
EMDN Code
V080399 Medical cushions - other
GMDN Term
Musculoskeletal hot/cold therapy pack, reusable
Device Class
Class I
Regulation Number
890.3490
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06498333011222
GUDID
00649833301122

Other devices from Brownmed, Inc.

See all devices from Brownmed, Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No