OneTouch Verio Control Solution

FDA UDIEUDAMED

Class I (US FDA UDI)

by Lifescan Europe

Identity

Trade Name: OneTouch Verio Control Solution FDA UDI
Generic Name: Glucose monitoring system IVD, point-of-care FDA UDI
Model / Reference: 011818 FDA UDI

Identifiers

Catalog Number: 01181803 FDA UDI
Primary DI / UDI-DI: 00353885011969 FDA UDI
FDA Product Code: JJX FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, point-of-care 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, point-of-care

OneTouch Verio Control Solution by Lifescan Europe — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, point-of-care.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Lifescan Europe

Sources (2)

FDA UDI 89d7cf85-84e0-4f5d-a4de-8647f5642654 34 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced Jun 2, 2026