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Mac 7

by GE Medical Systems Information Technologies, Inc.

Ref 2109091-001Model MAC 7

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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
United StatesGUDID listing GUDID Number00840682144322 UDI-DI Date13 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00013GM Basic UDI-DI 00840682144322UDI-DIDate20 May 2022RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Mac 7 EUDAMED
Mac GUDID
Generic Name
Electrocardiograph, professional, multichannel
Device Name
Resting ECG Analysis System
Model / Ref / Catalog
MAC 7, 2109091-001, 7
Primary DI / UDI-DI
00840682144322
Basic UDI-DI
8406821BUG00013GM
510(k) Number
FDA Product Code
DPS, DQK, DXH
EMDN Code
Z12050301 General purpose electrocardiographs
GMDN Term
Electrocardiograph, professional, multichannel
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2340, 870.1425, 870.2920
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MAC 7
2109091-001
GUDID
7
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No