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SGI60 Infuser
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FP-0010002Model Infusion Pump
Identity
- Trade Name
- SGI60 Infuser EUDAMEDSCIg60 Infusion System FDA UDI
- Generic Name
- Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI
- Device Name
- SGIg60 Infusion Pump EUDAMEDSCIg60 Infuser (Mechanical Pump) Assembly FDA UDI
- Model / Reference
- Infusion Pump EUDAMEDFP-0010002 EUDAMEDFDA UDI
- Description
- SCIg60 Infuser (Mechanical Pump) Assembly FDA UDI
Identifiers
- Catalog Number
- FP-0010002 FDA UDI
- Primary DI / UDI-DI
- 00817708020274 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817708020274 EUDAMED
- FDA Product Code
- PKP FDA UDI
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
- GMDN Term
- Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
SGI60 Infuser by EMED Technologies Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817708020274 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 cbb2823a-61a1-4766-aa26-85fd3155b635 61 fields · synced Jul 25, 2026
- FDA UDI 364e8ce6-8ce6-4f64-b5d8-6a56fb2f523d 37 fields · synced May 30, 2026