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FreedomEdge Syringe Driver
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref F10020Model FreedomEdge Syringe Driver
Identity
- Trade Name
- FreedomEdgeTM FDA UDI
- Generic Name
- Elastomeric infusion pump system filling device FDA UDI
- Device Name
- FreedomEdge Syringe Driver EUDAMEDMechanical Syringe Infusion Pump FDA UDI
- Model / Reference
- FreedomEdge Syringe Driver EUDAMEDF10020 EUDAMEDFDA UDI
- Description
- Mechanical Syringe Infusion Pump FDA UDI
Identifiers
- Catalog Number
- F10020 FDA UDI
- Primary DI / UDI-DI
- 00659443000018 EUDAMEDFDA UDI
- Basic UDI-DI
- 065944301PE EUDAMED
- Direct Marketing DI
- 00659443000018 EUDAMED
- FDA Product Code
- PKP FDA UDIFPA FDA UDIFRN FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Elastomeric infusion pump system filling device FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI880.5440 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
FreedomEdge Syringe Driver by KORU Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 065944301PE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- KORU Medical Systems, Inc
- EUDAMED SRN
- US-MF-000025369
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 80bd5bcd-9dc0-47c3-88a4-cb424864f72c 61 fields · synced Jul 15, 2026
- FDA UDI 82a71a59-166b-4aab-ac93-cd445d0738e9 36 fields · synced May 30, 2026