Crono
FDA UDIEUDAMEDClass II (US FDA UDI)
by Cane' Spa
Identity
- Trade Name
- Crono EUDAMEDFDA UDI
- Generic Name
- Ambulatory non-insulin infusion pump, electronic FDA UDI
- Device Name
- The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the controlled subcutaneous administration of immunoglobulin. FDA UDI
- Model / Reference
- THA pumps EUDAMEDPS3ML EUDAMEDS-PID 50 FDA UDI
- Description
- The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the controlled subcutaneous administration of immunoglobulin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050616613240 EUDAMED08050616612007 FDA UDI
- Basic UDI-DI
- 805061661-PS-THA-8G EUDAMED
- Direct Marketing DI
- 08050616613240 EUDAMED
- 510(k) Number
- K091042 FDA UDI
- FDA Product Code
- FRN FDA UDI
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
- GMDN Term
- Ambulatory non-insulin infusion pump, electronic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Ambulatory non-insulin infusion pump, electronic
Crono by Cane' Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Cane' Spa
Sources (2)
- FDA UDI fc7d14c9-999a-4a16-9522-e02ed89d5821 35 fields · synced Jul 31, 2026
- EUDAMED 6241043d-4bc9-4113-8f11-c23cbd1e126e 61 fields · synced Jul 31, 2026