BV Medical

FDA UDI

Class I (US FDA UDI)

by Medical, Inc.

Identity

Trade Name: BV Medical FDA UDI
Generic Name: Mechanical external stethoscope FDA UDI
Device Name: Combo Kit: Pink Breast Cancer Awareness Fanny Pack Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula FDA UDI
Model / Reference: 80-510-010-OTO-L FDA UDI
Description: Combo Kit: Pink Breast Cancer Awareness Fanny Pack Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula FDA UDI

Identifiers

Primary DI / UDI-DI: 00845821027467 FDA UDI
FDA Product Code: LDE FDA UDI
ERA FDA UDI
GMDN Term: Mechanical external stethoscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.1875 FDA UDI
874.4770 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mechanical external stethoscope Otoscope, direct

BV Medical by Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
Firefly — Firefly Global · Class I
Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
Welch Allyn, Inc. — Welch Allyn, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Medical, Inc.

Sources (1)

FDA UDI b94bc0bb-a3c5-4d96-bfee-0fbabbccf409 34 fields · synced Jun 1, 2026