Bk Medical ApS

Address:MILEPARKEN 34,HERLEV Hovedstaden,DK

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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

Transducer, Ultrasonic, Diagnostic (ITX) (10)

Premarket Exempt

Clear

9C2 Transducer - 05704916000011 Catalog Number :

Device Description : Abdominal, Fetal (including Obstetrics), Pediatrics, Musculoskeletal (Convention Abdominal, Fetal (including Obstetrics), Pediatrics, Musculoskeletal (Conventional), Peripheral Vessel (Peripheral Vascular)

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

X18L5s Transducer - 05704916000028 Catalog Number :

Device Description : "Intraoperative imaging, Peripheral Vessel (Peripheral Vascular), Small Organ ( "Intraoperative imaging, Peripheral Vessel (Peripheral Vascular), Small Organ (Small Parts),Musculoskeletal (Superficial and Conventional) imaging"

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

13L4w Transducer - 05704916000035 Catalog Number :

Device Description : Musculoskeletal (Superficial and Conventional), Small Organ (Small Parts), Perip Musculoskeletal (Superficial and Conventional), Small Organ (Small Parts), Peripheral Vessel (Peripheral Vascular), Pediatrics

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

I14C5I Transducer - 05704916000042 Catalog Number :

Device Description : Intraoperative, PediatricsMusculoskeletal PediatricPeripheral vascularInterventi Intraoperative, PediatricsMusculoskeletal PediatricPeripheral vascularInterventional Procedures

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

I14C5T Transducer - 05704916000059 Catalog Number :

Device Description : Intraoperative imaging, Abdominal imaging

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

E14C4t Transducer - 05704916000066 Catalog Number :

Device Description : Transrectal, Transvaginal

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

E10C4 Transducer - 05704916000073 Catalog Number :

Device Description : Transrectal, Transvaginal, Fetal (incl. Obstetrics)

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

10L2w Transducer - 05704916000080 Catalog Number :

Device Description : Peripheral Vessel (vascular)

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

6C2s Transducer - 05704916000097 Catalog Number :

Device Description : Abdominal, Fetal, Pediatrics

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

I12C5b Transducer - 05704916000103 Catalog Number :

Device Description : Intraoperative, Musculoskeletal (conventional), Peripheral Vessel (peripheral vascular)

Device Class : 2

Duns Number: 310093901

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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