Identity
- Trade Name
- GETINGE CM320-SERIES FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- CM320-4 CHAMBER WUWD. Washer disinfector with four chambers; Washer chamber followed by Ultra-sonic chamber, washer chamber and dryer chamber. FDA UDI
- Model / Reference
- CM320 FDA UDI
- Description
- CM320-4 CHAMBER WUWD. Washer disinfector with four chambers; Washer chamber followed by Ultra-sonic chamber, washer chamber and dryer chamber. FDA UDI
Identifiers
- Catalog Number
- CM320WUWD FDA UDI
- Primary DI / UDI-DI
- 07340153700192 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical utensil washer/disinfector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 Cm320-Series by Getinge Disinfection, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical utensil washer/disinfector.
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- WD1260-SC-060 — Smeg S.p.A. · Class IIb
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- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Getinge Disinfection, Inc.
Sources (1)
- FDA UDI 7bd41f21-7924-43fc-8971-aad8aa7f3728 34 fields · synced Jun 8, 2026