E-LINK N100 Small Goniometer

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: E-LINK N100 Small Goniometer FDA UDI
Generic Name: Electronic goniometer/kinesiology sensor FDA UDI
Device Name: Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motion Wrist – active and passive, extension and flexion, radial and ulnar deviation This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference: N100 FDA UDI
Description: Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motion Wrist – active and passive, extension and flexion, radial and ulnar deviation This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481692427 FDA UDI
FDA Product Code: ISD FDA UDI
KQX FDA UDI
GMDN Term: Electronic goniometer/kinesiology sensor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5360 FDA UDI
888.1500 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electronic goniometer/kinesiology sensor

E-LINK N100 Small Goniometer by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Biometrics Limited

Sources (1)

FDA UDI 2d2ea3dd-46e8-4d99-82a2-4279b9c5f424 33 fields · synced May 30, 2026