Caremed

FDA UDI

Class II (US FDA UDI)

by Shenzhen Caremed Medical Technology Co., Ltd.

Identity

Trade Name: Caremed FDA UDI
Generic Name: Electrocardiographic lead set, reusable FDA UDI
Device Name: Caremed ECG lead wire FDA UDI
Model / Reference: EHP3R-90P-A FDA UDI
Description: Caremed ECG lead wire FDA UDI

Identifiers

Catalog Number: EHP3R-90P-A FDA UDI
Primary DI / UDI-DI: 06970758507622 FDA UDI
510(k) Number: K153188 FDA UDI
FDA Product Code: DSA FDA UDI
GMDN Term: Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2900 FDA UDI
Commercial Distribution: Not 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Caremed by Shenzhen Caremed Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K153188 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: Shenzhen Caremed Medical Technology Co., Ltd.

Sources (1)

FDA UDI ec601765-686a-4ae0-9fd0-046cbf65fe44 36 fields · synced May 30, 2026