← Back to catalogue

Surelead

FDA UDI

Class II (US FDA UDI)

by Authentic Medical

Identity

Trade Name
Surelead FDA UDI
Generic Name
Electrocardiographic lead switching adaptor FDA UDI
Model / Reference
TCGE2GE5S FDA UDI

Identifiers

Primary DI / UDI-DI
B631TCGE2GE5S1 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead switching adaptor 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead switching adaptor

The Surelead Electrocardiographic lead switching adaptor is a reusable device used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations, enabling devices from different manufacturers to mate together. It typically features implantable functionality, making it an ideal solution for applications where different devices need to be connected.

Similar devices

Also classified as Electrocardiographic lead switching adaptor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Authentic Medical

Sources (1)

  • FDA UDI 6600df5d-b745-49c9-9753-4d166b8aa950 32 fields · synced Jun 25, 2026