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SHAPER No.1

FDA UDI

Class II (US FDA UDI)

by Timpel S/A

Identity

Trade Name
SHAPER No.1 FDA UDI
Generic Name
Electrical impedance skin electrode chest positioner FDA UDI
Device Name
The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized. FDA UDI
Model / Reference
AD-05001 FDA UDI
Description
The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized. FDA UDI

Identifiers

Primary DI / UDI-DI
07898959841262 FDA UDI
FDA Product Code
QEB FDA UDI
GMDN Term
Electrical impedance skin electrode chest positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1505 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrical impedance skin electrode chest positioner

SHAPER No.1 by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical impedance skin electrode chest positioner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Timpel S/A

Sources (1)

  • FDA UDI c694b488-5978-4d19-b725-2401c97b02f2 35 fields · synced May 30, 2026