CeQur Simplicity

FDA UDI

Class II (US FDA UDI)

by Cequr SA

Identity

Trade Name: CeQur Simplicity FDA UDI
Generic Name: Ambulatory insulin infusion pump reservoir FDA UDI
Device Name: CeQur Simplicity™ Insulin Delivery Patch FDA UDI
Model / Reference: CQR-S-2U01 FDA UDI
Description: CeQur Simplicity™ Insulin Delivery Patch FDA UDI

Identifiers

Primary DI / UDI-DI: 00373108000006 FDA UDI
510(k) Number: K163357 FDA UDI
FDA Product Code: OPP FDA UDI
LZG FDA UDI
GMDN Term: Ambulatory insulin infusion pump reservoir FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump reservoir

CeQur Simplicity by Cequr SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump reservoir.

t:flex Insulin Pump, Replacement — Tandem Diabetes Care, Inc. · Class II
t:slim G4 Cartridge 2 Pack — Tandem Diabetes Care, Inc. · Class III
t:flex Insulin Pump, Replacement, Refurbished — Tandem Diabetes Care, Inc. · Class II
iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
Tandem t:slim AutoSoft XC Kit — Tandem Diabetes Care, Inc. · Class II
t:slim X2 Cartridge, t:lock, 10 Pack — Tandem Diabetes Care, Inc. · Class II
t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc. · Class II
Tandem Mobi Autosoft XC Kit — Tandem Diabetes Care, Inc. · Class II

Cleared under the same submission

K163357 also covers:

CeQur Simplicity — Cequr SA
CeQur Simplicity — Cequr SA

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: Cequr SA

Sources (1)

FDA UDI db1e098d-1cd1-422e-9a93-af5e16718131 34 fields · synced May 30, 2026