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Changke Connect

FDA UDI

Class II (US FDA UDI)

by Shenzhen Changke Connect Electronics Co., Ltd.

Identity

Trade Name
Changke Connect FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Model / Reference
P01-001-00565 FDA UDI

Identifiers

Primary DI / UDI-DI
06973874210131 FDA UDI
510(k) Number
K200026 FDA UDI
FDA Product Code
DSA FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead set, single-use

Changke Connect by Shenzhen Changke Connect Electronics Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, single-use.

Cleared under the same submission

K200026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Changke Connect Electronics Co., Ltd.

Sources (1)

  • FDA UDI ced31bae-9335-42e3-93c9-f5dd6d23268c 33 fields · synced May 30, 2026