← Back to catalogue
Automated Blood Coagulation Analyzer CS-2100i
FDA UDIClass II (US FDA UDI)
by Sysmex Corp.
Identity
- Trade Name
- Automated Blood Coagulation Analyzer CS-2100i FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- CS-2100i COMPLETE FDA UDI
- Model / Reference
- 06372511 FDA UDI
- Description
- CS-2100i COMPLETE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562409471 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Automated Blood Coagulation Analyzer CS-2100i by Sysmex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 4ccd053f-29a5-446b-9b72-30be2c28f8ee 35 fields · synced May 30, 2026