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Perfect 3

FDA UDI

Class I (US FDA UDI)

by Biotest Medical Corporation

Identity

Trade Name
Perfect 3 FDA UDI
Generic Name
Glucose analyser IVD, home-use/point-of-care, line-powered FDA UDI
Device Name
Perfect 3 Meter Only FDA UDI
Model / Reference
6268 FDA UDI
Description
Perfect 3 Meter Only FDA UDI

Identifiers

Primary DI / UDI-DI
04719871820247 FDA UDI
FDA Product Code
JJX FDA UDI
CGA FDA UDI
NBW FDA UDI
GMDN Term
Glucose analyser IVD, home-use/point-of-care, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
862.1345 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose analyser IVD, home-use/point-of-care, line-powered

Perfect 3 by Biotest Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose analyser IVD, home-use/point-of-care, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotest Medical Corporation

Sources (1)

  • FDA UDI 18f48388-7737-421f-84d7-34272b4ba264 33 fields · synced May 30, 2026