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SCIg60 Infusion System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FP-0010002Model SCIg60 Infusion System510(k) K240148
Identity
- Trade Name
- SCIg60 Infusion System EUDAMED
- Device Name
- SCIg60® Infuser EUDAMED
- Model / Reference
- SCIg60 Infusion System EUDAMEDFP-0010002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-081770802MIP00142 EUDAMED
- Basic UDI-DI
- B-081770802MIP00142 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SCIg60 Infusion System by EMED Technologies Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240148 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K173783 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222087 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-081770802MIP00142 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
- EUDAMED SRN
- US-MF-000012148
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c71817e7-a897-44cb-ba7a-cb2110ef30b0 85 fields · synced Jun 18, 2026
- FDA 510(k) K240148 1 fields · synced May 18, 2026