Hi-bebe

FDA UDI

Class II (US FDA UDI)

by Bistos Co., Ltd.

Identity

Trade Name: Hi-bebe FDA UDI
Generic Name: Foetal Doppler system FDA UDI
Device Name: BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. FDA UDI
Model / Reference: BT-200C FDA UDI
Description: BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. FDA UDI

Identifiers

Primary DI / UDI-DI: 00887529000199 FDA UDI
510(k) Number: K052190 FDA UDI
FDA Product Code: HGM FDA UDI
GMDN Term: Foetal Doppler system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Foetal Doppler system Foetal Doppler system probe

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

Similar devices

Also classified as Foetal Doppler system probe.

T2M20S8C — Koven Technology, Inc. · Class II
CONTEC — Contec Medical Systems Co., Ltd. · Class II
CONTEC — Contec Medical Systems Co., Ltd. · Class II
US Transducer — Edan Instruments, Inc. · Class II
ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd. · Class II
Phased array probe — CHISON Medical Technologies Co., Ltd. · Class II
Paryvara — BOOT REMEDY LTD · Class II
ClearTone Doppler — CooperSurgical, Inc. · Class II

Cleared under the same submission

K052190 also covers:

Hi-bebe — Bistos Co., Ltd.
Hi-bebe — Bistos Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bistos Co., Ltd.

Sources (1)

FDA UDI a502361f-ae16-4b30-86fe-7d4cb36617c0 36 fields · synced May 29, 2026