UC-CARE LTD

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Retention Type, Balloon (EZL) (2) System, Image Processing, Radiological (LLZ) (2) Unit, Cryosurgical, Accessories (GEH) (1)

Premarket Exempt

Clear

Endocar Tamplate Fixator - 07290016936209 Catalog Number : FPRSA00023

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Probe sensor - 07290016936216 Catalog Number : FPRSA00024

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Warming System-unit, Cryosurgical - 07290016936223 Catalog Number : FPRMC00034

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Warming System-catheter - 07290016936230 Catalog Number : FPRMC00035

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

Positioning System - 07290016936247 Catalog Number : FPRMC00036

Device Class : 2

Duns Number: 649551124

Premarket Exempt : No

Product Code : EZL

Prescription Use : No

Device Count : 1

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