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Getinge 9100-Series 9125E

by Getinge Disinfection, Inc.

Ref 9125E-001

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73401537000382 Basic UDI-DI 07340153710047UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07340153710047 UDI-DI Date16 Nov 2017ListedStatusListed 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  • Withdrawn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
Getinge 9100-Series
Generic Name
Instrument chemical/thermal disinfector
Model / Ref / Catalog
9125E-001, 9125E
Primary DI / UDI-DI
07340153710047
Basic UDI-DI
73401537000382
FDA Product Code
MEC
EMDN Code
Z12011301 Cleaning and disinfection equipment
GMDN Term
Instrument chemical/thermal disinfector
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.6992
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
9125E-001
GUDID
9125E
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

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