BEURER NORTH AMERICA, L.P.

Address:1 Oakwood Boulevard, Suite 255,Hollywood,FL,33020,US

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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

Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (4) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3) Analyzer, Body Composition, Exempt (PUH) (2) Hearing Aid, Air Conduction (ESD) (1)

Premarket Exempt

No Yes

Clear

Beurer - 00852547004924 Catalog Number :

Device Description : Glass Body Analysis Scale

Device Class : 2

Duns Number: 078497467

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

Vitalcontrol - 00852547004962 Catalog Number : Type: SBM46/1

Device Description : Upper Arm Blood Pressure Monitor

Device Class :

Duns Number: 078497467

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Beurer - 00853879007027 Catalog Number :

Device Description : Wearable air-conduction hearing aid - wearable sound-amplifying device that is i Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing.

Device Class :

Duns Number: 078497467

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Vitalcontrol - 00853879007034 Catalog Number : Art.-Nr. 662.23

Device Description : Mini TENS LowerBack

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Vitalcontrol - 00853879007041 Catalog Number : Art.-Nr. 662.19

Device Description : Mini TENS Arms & Legs Massage

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Beurer - 00853879007058 Catalog Number : Art.- No 659.69

Device Description : BM67 Bluetooth® Upper Arm Blood Pressure Monitor* with standard cuff 8.7 - 14.2 BM67 Bluetooth® Upper Arm Blood Pressure Monitor* with standard cuff 8.7 - 14.2 in (22 - 36 cm)* with universal cuff size 8.7 - 17.3 in (22 - 44 cm)

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Beurer - 00853879007065 Catalog Number :

Device Description : BF70 Bluetooth® Diagnostic Scale

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : PUH

Prescription Use : No

Device Count : 1

Beurer - 00853879007072 Catalog Number : Type KD-721

Device Description : Wrist Bluetooth® Blood Pressure Monitor

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Vital Control - 00853879007089 Catalog Number :

Device Description : TENS / EMS Device

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Vitalcontrol - 00853879007096 Catalog Number :

Device Description : Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and aching muscles

Device Class : 2

Duns Number: 078497467

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

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