← Back to catalogue
Getinge 9100-Series
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 9122EW-001Ref 9125E-001
Identity
- Trade Name
- GETINGE 9100-SERIES FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- Getinge 9100-Series EUDAMEDWASHER DISINFECTOR 9122EW FDA UDIWASHER DISINFECTOR 9128EW FDA UDIWASHER DISINFECTOR 9125E FDA UDI
- Model / Reference
- 9122EW-001 EUDAMED9125E-001 EUDAMED9122EW FDA UDI9128EW FDA UDI9125E FDA UDI
- Description
- WASHER DISINFECTOR 9122EW FDA UDIWASHER DISINFECTOR 9128EW FDA UDIWASHER DISINFECTOR 9125E FDA UDI
Identifiers
- Catalog Number
- 9122EW-001 FDA UDI9128EW-001 FDA UDI9125E-001 FDA UDI
- Primary DI / UDI-DI
- 07340153710030 EUDAMEDFDA UDI07340153710047 EUDAMEDFDA UDI07340153710078 FDA UDI
- Basic UDI-DI
- 73401537000382 EUDAMED
- FDA Product Code
- MEC FDA UDI
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
- GMDN Term
- Surgical utensil washer/disinfector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
Getinge 9100-Series by Getinge Disinfection, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical utensil washer/disinfector.
- Steelco — STEELCO SPA · Class II
- Antiseptic Applicator — Poly Medicure Limited · Class I
- WD1260-SC-060 — Smeg S.p.A. · Class IIb
- Getinge Aquadis Index — GETINGE DISINFECTION AB · Class IIa
- Sümer — SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIb
- Getinge ED-FLOW AER RANGE — GETINGE DISINFECTION AB · Class IIb
- CS 750 — Belimed Infection Control AG · Class IIa
- WD7015TM — Smeg S.p.A. · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Getinge Disinfection, Inc.
Sources (5)
- FDA UDI 348c2e8b-f7f4-4c15-93f5-ec7798edc7bc 34 fields · synced Aug 4, 2026
- FDA UDI 247920e5-65e0-48ff-a70e-ce07d6627461 34 fields · synced May 24, 2026
- FDA UDI a4f20205-01dc-4446-bd5e-56868db04c06 34 fields · synced May 30, 2026
- EUDAMED d7049174-2121-4dec-a05b-0b6e11ab3d3e 61 fields · synced Jul 23, 2026
- EUDAMED 9ba9cd55-b12a-4665-a9a6-92a9e2490efd 61 fields · synced Aug 4, 2026