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Holter Recorder

by DM Systems (Beijing) Co., Limited EUDAMEDGUDID

Active European Union and United States

Ref MDA 0203Model DMS300-4AL, DMS300-3A, DMS300-2W, DMS300-4A

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975817741023 UDI-DIDate22 Jul 2026ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-06975817741023 Basic UDI-DIDate13 May 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Holter Recorder EUDAMED
DMS 300-4A Holter Recorder GUDID
DMS 300-4AL Holter Recorder GUDID
DMS 300-2W Holter Recorder GUDID
DMS 300-3A Holter Recorder GUDID
Generic Name
Electrocardiographic ambulatory recorder
Model / Ref / Catalog
DMS300-4AL EUDAMED
MDA 0203 EUDAMED
DMS300-3A EUDAMED
DMS300-2W EUDAMED
DMS300-4A EUDAMED
DMS 300-4A GUDID
DMS 300-4AL GUDID
DMS 300-2W GUDID
DMS 300-3A GUDID
DMS 300-4A Holter Recorder GUDID
DMS 300-4AL Holter Recorder GUDID
DMS 300-2W Holter Recorder GUDID
DMS 300-3A Holter Recorder GUDID
Primary DI / UDI-DI
06975817741023, 06975817741016, 06975817741054, 06975817741047
Basic UDI-DI
B-06975817741023, B-06975817741016, B-06975817741054, B-06975817741047
510(k) Number
FDA Product Code
MWJ
EMDN Code
Z12050403 ECG holter recorders
GMDN Term
Electrocardiographic ambulatory recorder
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2800
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DMS300-4AL
MDA 0203
DMS300-3A
DMS300-2W
DMS300-4A
GUDID
DMS 300-4A
DMS 300-4AL
DMS 300-2W
DMS 300-3A
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000021147
Authorised representative
ADVANCED MEDICAL SYSTEMS SL ES-AR-000019175

Other devices from DM Systems (Beijing) Co., Limited

Properties

Show properties
  • Measuring Function
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No