Question 1

What types of medical devices does UC-Care Ltd manufacture?

Accepted Answer

UC-Care Ltd specializes in the production of rectal ultrasound navigational image processors, sterile urinary catheter holders, and cryosurgical sets. Their product portfolio includes various probe sensor assemblies compatible with specific ultrasound systems, cryosurgical warming system units, and the Navigo workstation. This information is provided to clarify the scope of the company's manufacturing activities based on their current product offerings.

Question 2

Where is UC-Care Ltd based and how are their devices classified?

Accepted Answer

UC-Care Ltd is based in the US. Their medical devices are classified as Class II. This classification is determined by the regulatory requirements associated with the specific types of equipment they produce, ensuring that users understand the risk category and regulatory framework under which these products operate.

Question 3

Which regulatory registries list the devices produced by UC-Care Ltd?

Accepted Answer

The devices manufactured by UC-Care Ltd are listed in the FDA 510(k) and FDA UDI databases. These registries are used to track medical devices that have met specific regulatory requirements for market entry, providing transparency regarding the documentation and identification standards maintained for their product line.

Device	Model / Reference	Registries	Class	Status
Probe sensor assembly for GE E8CS (square)	FPRSA00009	FDA UDI	Class II	Active
Navigo™ Workstation	FPRMC0016A	FDA UDI	Class II	Active
Probe sensor assembly for Hitachi V53W (square)	FPRSA00008	FDA UDI	Class II	Active
Probe sensor assembly for BK 8818 and 8808e (square)	FPRSA00007	FDA UDI	Class II	Active
Probe sensor assembly for GE E8CS	FPRSA00014	FDA UDI	Class II	Active
Warming System-unit, Cryosurgical	FPRMC00034	FDA UDI	Class II	Active
Probe sensor assembly for GE BE9CS	FPRSA00019	FDA UDI	Class II	Active
Probe sensor assembly for Hitachi V53W	FPRSA00012	FDA UDI	Class II	Active
Probe sensor assembly for Hitachi EUP-U533	FPRSA00018	FDA UDI	Class II	Active
Probe sensor assembly for MindRay	FPRSA00013	FDA UDI	Class II	Active
Probe sensor assembly for BK 8667 (square)	FPRSA00011	FDA UDI	Class II	Active
Probe sensor assembly for EndoCare	FPRSA00015	FDA UDI	Class II	Active
Warming System-catheter	FPRMC00035	FDA UDI	Class II	Active
Civco classic stepper sensor fixator	FPRSA00022	FDA UDI	Class II	Active
Probe sensor assembly for Philips BP10-5es	FPRSA00020	FDA UDI	Class II	Active
Ascension transmitter Cubic Assembly	ASMCH00034	FDA UDI	Class II	Active
Computer (Industrial)	FPRCO00011	FDA UDI	Class II	Active
Probe sensor assembly for Civco 8848	FPRSA00017	FDA UDI	Class II	Active
Roll Stand + Arm	HRDGN00023	FDA UDI	Class II	Active
Positioning System	FPRMC00036	FDA UDI	Class II	Active
Endocar Tamplate Fixator	FPRSA00023	FDA UDI	Class II	Active
Probe sensor	FPRSA00024	FDA UDI	Class II	Active
Probe sensor assembly for D&K 8848	FPRSA00016	FDA UDI	Class II	Active
D&K Stepper template fixator	FPRSA00021	FDA UDI	Class II	Active
Probe sensor assembly for BK 8808 (square)	FPRSA00006	FDA UDI	Class II	Active
Uc-Care Navigo Sytem	K100784	FDA 510(k)	Class II	Active
Navigo Workstation Version 2.0	K173054	FDA 510(k)	Class II	Active
UC-CARE NaviGo Workstation	K160934	FDA 510(k)	Class II	Active
Uc-Care Warming System	K090978	FDA 510(k)	Class II	Active
Navigo Workstation 2.3 (FPRMC00039)	K250664	FDA 510(k)	Class II	Active

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