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Hi-dop

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bistos Co., Ltd.

Identity

Trade Name
Hi-dop FDA UDI
Generic Name
Foetal Doppler system probe FDA UDI
Device Name
Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200V irradiates fetal wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus. 4, 5, 8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate(PR) they are able to check vascular blood flow status. BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient. FDA UDI
Model / Reference
BT-200V FDA UDI
Description
Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200V irradiates fetal wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus. 4, 5, 8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate(PR) they are able to check vascular blood flow status. BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient. FDA UDI

Identifiers

Catalog Number
OSD-14200V-001 FDA UDI
Primary DI / UDI-DI
00887529000014 FDA UDI
510(k) Number
K121267 FDA UDI
FDA Product Code
HGM FDA UDI
GMDN Term
Foetal Doppler system probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Foetal Doppler systemFoetal Doppler system probe

Hi-dop by Bistos Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Foetal Doppler system probe.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bistos Co., Ltd.

Sources (2)

  • FDA UDI 39299a8a-efad-4587-a71c-9ac6383c934a 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026