Identity
- Device Name
- Getinge ED-FLOW AER RANGE EUDAMED
- Model / Reference
- P01280010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340153711112 EUDAMED
- Basic UDI-DI
- 7340153700107X EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Surgical utensil washer/disinfector
Getinge ED-FLOW AER RANGE by Getinge Disinfection Ab — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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- Steelco — STEELCO SPA · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7340153700107X | Class IIb | Active |
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Manufacturer
- Manufacturer
- Getinge Disinfection AB
- EUDAMED SRN
- SE-MF-000001012
Sources (1)
- EUDAMED e3e0ae40-2325-4b10-8ace-a9c03b60637a 61 fields · synced Jul 20, 2026