Apk

FDA UDI

Class II (US FDA UDI)

by Apk Technology

Identity

Trade Name: APK FDA UDI
Generic Name: Electrocardiographic lead set, reusable FDA UDI
Device Name: CABLES FDA UDI
Model / Reference: A5055-EL0 FDA UDI
Description: CABLES FDA UDI

Identifiers

Primary DI / UDI-DI: 06946725522752 FDA UDI
FDA Product Code: IKD FDA UDI
GMDN Term: Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

Apk by Apk Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
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Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, 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: Apk Technology

Sources (1)

FDA UDI 0541e577-f228-45fc-b191-948b599c89ca 33 fields · synced May 31, 2026