Bovie

FDA UDI

Class II (US FDA UDI)

by Bovie Medical Corporation

Identity

Trade Name: Bovie FDA UDI
Generic Name: Foetal Doppler system probe FDA UDI
Device Name: ACUDOP LL 2MHZ OB PROBE (ONLY) FDA UDI
Model / Reference: A2 FDA UDI
Description: ACUDOP LL 2MHZ OB PROBE (ONLY) FDA UDI

Identifiers

Catalog Number: A2 FDA UDI
Primary DI / UDI-DI: 10607151011656 FDA UDI
510(k) Number: K090465 FDA UDI
FDA Product Code: LXE FDA UDI
ITX FDA UDI
GMDN Term: Foetal Doppler system probe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.2660 FDA UDI
892.1570 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

FDA UDI

Category: Foetal Doppler system probe

Bovie by Bovie Medical Corporation — 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
Hi-dop — Bistos Co., Ltd. · Class II
CONTEC — Contec Medical Systems Co., Ltd. · Class II
US Transducer — Edan Instruments, Inc. · Class II
Hi-bebe — Bistos Co., Ltd. · Class II
ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd. · Class II
Phased array probe — CHISON Medical Technologies Co., Ltd. · Class II

Cleared under the same submission

K090465 also covers:

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: Bovie Medical Corporation

Sources (1)

FDA UDI e5b559ce-9851-4ff2-a841-96ed559c60ca 36 fields · synced Jun 6, 2026