Comfort EZ Safety Lancet

FDA UDI

Class II (US FDA UDI)

by Simple Diagnostics

Identity

Trade Name: Comfort EZ Safety Lancet FDA UDI
Generic Name: Blood lancing device tip FDA UDI
Device Name: Safety Lancet 28G 1.5mm Depth FDA UDI
Model / Reference: CLES10028 FDA UDI
Description: Safety Lancet 28G 1.5mm Depth FDA UDI

Identifiers

Catalog Number: 98302-0140-20 FDA UDI
Primary DI / UDI-DI: 00898302140209 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Blood lancing device tip FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 26 Gauge FDA UDI
Depth — 1.5 Millimeter FDA UDI

Category: Blood lancet, single-use Blood lancing device tip

Comfort EZ Safety Lancet by Simple Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II

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: Simple Diagnostics

Sources (1)

FDA UDI 106dadb0-1ca7-45ad-89a4-5de6e113a791 36 fields · synced Jun 1, 2026