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Getinge 86-Series
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref S-86682003Ref S-86662003Ref S-8668T1001
Identity
- Trade Name
- Getinge 86-Series FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- Getinge 86-Series EUDAMEDS-8668T Double door FDA UDIS-8668T with single door FDA UDIWASHER DISINFECTOR Cat. No. updated from S-86681003 to S-86682003 FDA UDIWASHER DISINFECTOR Cat.No updated from S-86662001 to S-86662003 FDA UDI
- Model / Reference
- S-86682003 EUDAMEDS-86662003 EUDAMEDS-8668T1001 EUDAMEDS-8668T FDA UDIS-8668 FDA UDIS-8666 FDA UDI
- Description
- S-8668T Double door FDA UDIS-8668T with single door FDA UDIWASHER DISINFECTOR Cat. No. updated from S-86681003 to S-86682003 FDA UDIWASHER DISINFECTOR Cat.No updated from S-86662001 to S-86662003 FDA UDI
Identifiers
- Catalog Number
- S-8668T1003 FDA UDIS-8668T1001 FDA UDIS-86682003 FDA UDIS-86662003 FDA UDI
- Primary DI / UDI-DI
- 07340153710269 EUDAMEDFDA UDI07340153700277 EUDAMEDFDA UDI07340153700253 EUDAMEDFDA UDI07340153710276 FDA UDI
- Basic UDI-DI
- 7340153700027Y 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 86-Series by Getinge Disinfection, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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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 |
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Manufacturer
- Manufacturer
- Getinge Disinfection, Inc.
Sources (7)
- FDA UDI 698ef7fe-3194-45f1-bc3c-5e1723c410bf 34 fields · synced Jul 11, 2026
- FDA UDI d34c8f6e-97c3-403b-a8e2-865526bc5de0 34 fields · synced May 30, 2026
- FDA UDI eb123d15-2bba-4195-a35f-223b5731a002 34 fields · synced May 30, 2026
- FDA UDI a4f407e3-01d1-46ab-885f-6adbda5d8074 34 fields · synced May 30, 2026
- EUDAMED 99c48fab-352a-4212-bbf0-1e6b79ce4238 61 fields · synced Jul 10, 2026
- EUDAMED 7e94f2f3-5e1a-42e4-a1f8-62dd822b4cb2 61 fields · synced Jul 10, 2026
- EUDAMED 41c132c1-6e31-4438-aa04-62b06a2f8415 61 fields · synced Jul 11, 2026