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Thermogenesis Corp.

United States·US-MF-000014232

Last updated September 17, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
SynGenX®-1000	SGI-0120-01	FDA UDI	Class II	Active
X-Lab	80067	FDA UDI	Class I	Active
X- Wash	80070	FDA UDI	Class I	Active
Pxp	80063	FDA UDI	Class II	Active
AutoXpress Platform Counterbalance CG	8-5144	FDA UDI	Class II	Active
SynGen® DataTrak	SGI-0777	FDA UDI	Class II	Active
MXP Processing Bagset	8-5137	FDA UDI	Class I	Active
Auto Volume Expressor	8-4100-0	FDA UDI	Class II	Active
3D Bag Set	80105	FDA UDI	Class I	Active
ThermoGenesis AXP	80056-RFB	EUDAMEDFDA UDI	Class II	Active
AXP Adapter, 101-102mm Round Bucket	8-5113	FDA UDI	Class II	Active
SynGenX®-1000	SGI-0046-01	FDA UDI	Class II	Active
Pxp-Lavare	80120	FDA UDI	Class II	Active
Pxp-1000	80104	FDA UDI	Class II	Active
X-Wash	80086	FDA UDI	Class I	Active
Thermogenesis Start Up Accessory Kit, MarrowXpress	8-5142	FDA UDI	Class I	Active
X-Lab	80060	FDA UDI	Class I	Active
Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (primary)	K081345	FDA 510(k)	Class I	Active
Thermogenesis Drop Applicator, Kits, Spray Kits And Tips	K955282	FDA 510(k)	Class II	Active
Cryoseal Fs Applicator System	K071126	FDA 510(k)	Class II	Active
XpressTrak	6-00-066	EUDAMEDFDA UDI	Class I	Active
AXP II Docking Station	80055	EUDAMEDFDA UDI	Class I	Active
Axp	8-5110	EUDAMEDFDA UDI	Class I	Active
AXP Device	8-5103	EUDAMEDFDA UDI	Class IIa	Active
Axp	8-5101	EUDAMEDFDA UDI	Class IIa	Active
AXP Start Up Accessory Kit	8-5100	EUDAMEDFDA UDI	Class I	Active
Xp	8-5102	EUDAMEDFDA UDI	Class IIa	Active

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