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Definium Pace Select ET

by GE HUALUN MEDICAL SYSTEMS CO. Ltd 2 variants

Ref B2600UDIModel Definium Pace Select ET

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08406821BUG005206X Basic UDI-DI 00195278913807UDI-DIDate11 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278913807 UDI-DI Date30 Oct 2024ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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
Definium
Generic Name
Stationary basic diagnostic x-ray system, digital
Device Name
Definium Pace Select ET
Model / Ref / Catalog
Definium Pace Select ET, B2600UDI, Pace Select ET
Primary DI / UDI-DI
00195278913807
Basic UDI-DI
08406821BUG005206X
Direct Marketing DI
00195278913807
510(k) Number
FDA Product Code
MQB, KPR
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
GMDN Term
Stationary basic diagnostic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1680
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Definium Pace Select ET
B2600UDI
GUDID
Pace Select ET
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000001189
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Hualun Medical Systems Co., Ltd

See all devices from GE Hualun Medical Systems Co., Ltd →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

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