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Intrelief Combo

by EasyMed Instruments Co., Ltd.

Ref Intrelief Combo

Intrelief Combo is a medical device (EU MDR Class IIa; FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter; EMDN category muscle reinforcement stimulators for innervated muscles) made by EasyMed Instruments Co., Ltd., registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI 69428082E03XZ) and listed in FDA GUDID since 15 Nov 2021 (UDI-DI 06942808261068), active as of 18 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 18 Oct 2026.

Regulatory status

as of registry sync 18 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69428082E03XZ Basic UDI-DI 06942808261068UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06942808261068 UDI-DI Date15 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69428082E03XZ registered 28 Apr 2026 Active
  • FDA GUDID UDI-DI 06942808261068 listed 15 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06942808261068
  2. Registered EUDAMED 69428082E03XZ

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  • Withdrawn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
TENS/EMS Stimulator EUDAMED
Intrelief Combo GUDID
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
Intrelief Combo
Primary DI / UDI-DI
06942808261068
Basic UDI-DI
69428082E03XZ
Direct marketing DI
06942808261068
FDA product code
NUH
EMDN code
Z12062801 Muscle reinforcement stimulators for innervated muscles
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5890
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Similar devices in this category

Other devices filed under MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES.

Other devices from EasyMed Instruments Co., Ltd.

See all devices from EasyMed Instruments Co., Ltd. →

Properties

  • Over-the-counter
Other properties (24, all answered No)