Epatch 2.0

FDA UDI

Class II (US FDA UDI)

by Braemar Manufacturing, LLC

Identity

Trade Name: Epatch 2.0 FDA UDI
Generic Name: Electrocardiographic ambulatory recorder FDA UDI
Model / Reference: 02-01575 FDA UDI

Identifiers

Primary DI / UDI-DI: B146EP2010 FDA UDI
510(k) Number: K171410 FDA UDI
FDA Product Code: DSH FDA UDI
GMDN Term: Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2800 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: Electrocardiographic ambulatory recorder

Epatch 2.0 by Braemar Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Norav NR Series — Norav Medical Inc. · Class II
Smart ECG — MICROPORT CRM SRL · Class III

Cleared under the same submission

K171410 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: Braemar Manufacturing, LLC

Sources (1)

FDA UDI 3e7a1796-187d-4292-a4e8-79bace7a9d98 33 fields · synced Jun 9, 2026