Fc700

FDA UDI

Class II (US FDA UDI)

by Bionet Company, Ltd.

Identity

Trade Name: FC700 FDA UDI
Generic Name: Foetal cardiac monitor FDA UDI
Device Name: SYSTEM, MONITORING, PERINATAL FDA UDI
Model / Reference: FC700 FDA UDI
Description: SYSTEM, MONITORING, PERINATAL FDA UDI

Identifiers

Primary DI / UDI-DI: 08809276943590 FDA UDI
510(k) Number: K043597 FDA UDI
FDA Product Code: HGM FDA UDI
GMDN Term: Foetal cardiac monitor 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

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 cardiac monitor

Fc700 by Bionet Company, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Foetal cardiac monitor.

Compact FM — Avante · Class II
Fetal Monitor — Edan Instruments, Inc. · Class II
ADVANCED FETAL MONITOR — ADVANCED INSTRUMENTATIONS, INC. · Class II
Fetal monitor — Edan Instruments, Inc. · Class II
Compact Plus — Avante · Class II
Compact Plus — Avante · Class II
Compact Plus — Avante · Class II
Fetal & maternal monitor — Edan Instruments, Inc. · Class II

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: Bionet Company, Ltd.

Sources (1)

FDA UDI 6cd0c66b-4da2-4a9f-aa6c-0a2bc2be9f7b 34 fields · synced Jun 1, 2026