SafetiCet

FDA UDI

Class II (US FDA UDI)

by Nsp Tech Pte, Ltd.

Identity

Trade Name: SafetiCet FDA UDI
Generic Name: Blood lancet, single-use FDA UDI
Device Name: A sterile and single use device, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider or a patient (e.g., a diabetic), typically at the fingertip. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site FDA UDI
Model / Reference: SC-150 FDA UDI
Description: A sterile and single use device, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider or a patient (e.g., a diabetic), typically at the fingertip. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site FDA UDI

Identifiers

Catalog Number: SC-150-010 FDA UDI
Primary DI / UDI-DI: 18887629000029 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Blood lancet, single-use 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 28 Gauge FDA UDI
Depth — 1.5 Millimeter FDA UDI

Category: Blood lancet, single-use

SafetiCet by Nsp Tech Pte, Ltd. — 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: Nsp Tech Pte, Ltd.

Sources (1)

FDA UDI 9ea7e1f1-ec78-45cf-9e99-55abd878638e 37 fields · synced May 30, 2026