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Catalogue (112)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Automated Hematology Analyzer XE-2100D | 03309313 | FDA UDI | Class II | Active |
| Cellsheath C | CSC-300A | FDA UDI | Class I | Active |
| Stromatolyser-Wh | SWH-200A | FDA UDI | Class I | Active |
| Cellpack Dst | DST-300A | FDA UDI | Class I | Active |
| Automated Blood Coagulation Analyzer CS-2100i | 06372511 | FDA UDI | Class II | Unknown |
| Stromatolyser-Fb | FBA-200A | FDA UDI | Class I | Active |
| Cellpack-S | CPK-301A | FDA UDI | Class I | Active |
| Stromatolyser-4dl | 05433212 | FDA UDI | Class I | Active |
| Ret-Search Ii | RED-700A | FDA UDI | Class I | Active |
| Xw Qc Check | BP935764 | FDA UDI | Class II | Active |
| RANGE CHECK X ll | 130-4003-0 | FDA UDI | Class II | Unknown |
| Automated Blood Coagulation Analyzer CS-5100 | BY990757 | FDA UDI | Class II | Active |
| Fully Automated Urine Particle Analyzer UF-5000 | BN344411 | FDA UDI | Class II | Active |
| SCS-1000 Calibrator | 217685 | FDA UDI | Class II | Active |
| XW pack D | ZA900005 | FDA UDI | Class I | Active |
| Cellpack | PK-30L | FDA UDI | Class I | Active |
| Cellsheath Ccs | ZA900004 | FDA UDI | Class I | Active |
| e-CHECK(XS) | 199-5001-0 | FDA UDI | Class II | Active |
| pocH-pack L | PPL-200A | FDA UDI | Class I | Active |
| Uf Ii Pack-Bac | 06401712 | FDA UDI | Class I | Active |
| Automated Hematology Analyzer XP series XP-300 | AR408878 | FDA UDI | Class II | Active |
| Xn-L Check | AS747750 | FDA UDI | Class II | Active |
| UF-Cellpack SF | ZA900008 | FDA UDI | Class I | Active |
| X-CAL Calibrator | 110-4009-0 | FDA UDI | Class II | Active |
| pocH-pack D | PPD-300A | FDA UDI | Class I | Active |
| Stromatolyser-4dl | FFD-200A | FDA UDI | Class I | Active |
| Automated Hematology Analyzer XN series XN-11 | CS297931 | FDA UDI | Class II | Active |
| Automated Hematology Analyzer XS series XS-1000iC | BB046392 | FDA UDI | Class II | Active |
| XQ-320 XQ-Series Automated Hematology Analyzer | BU954129 | FDA UDI | Class II | Active |
| Wrp Check | BG234784 | FDA UDI | Class II | Active |
| Platelet CHECK | CN464998 | FDA UDI | Class II | Active |
| e-CHECK(XE) | 201-6001-0 | FDA UDI | Class II | Active |
| Ca Cal S | 014-1271-4 | FDA UDI | Class II | Active |
| Automated Hematology Analyzer XN-L series XN-330 | CX851950 | FDA UDI | Class II | Active |
| Wrp Check Ex | AX844619 | FDA UDI | Class II | Active |
| Uf Ii Pack-Sed | UPS-300A | FDA UDI | Class I | Active |
| UF ll CALIBRATOR | 06404310 | FDA UDI | Class I | Active |
| Platelet CHECK | CC118360 | FDA UDI | Class II | Active |
| Uf Ii Sheath | UTS-900A | FDA UDI | Class I | Active |
| Uf Ii Control | 06404115 | FDA UDI | Class I | Active |
| Automated Hematology Analyzer XN-L series XN-450 | BM392756 | FDA UDI | Class II | Active |
| Automated Hematology Analyzer XN series XN-20 | AE797961 | FDA UDI | Class II | Active |
| Uc Control | AU448468 | FDA UDI | Class I | Active |
| UDM (Urinalysis Data Manager) | 1.X | FDA UDI | Class I | Active |
| Sysmex(tm) F-820, 520 | K945837 | FDA 510(k) | Class II | Active |
| Analyzer, Model Cc-720 | K790026 | FDA 510(k) | Class II | Active |
| Sysmex Uf-50 | K012372 | FDA 510(k) | Class II | Active |
| Sysmex Immature Reticulocyte Fraction (irf) Parameter | K971736 | FDA 510(k) | Class II | Active |
| Sysmex Ca-1000/Sysmex Ca-5000 | K964946 | FDA 510(k) | Class II | Active |
| Toa Medical Electronics Ca-1000 | K942096 | FDA 510(k) | Class II | Active |
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