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Disposable Safety Lancets

EUDAMED

Class IIa (EU MDR)

Ref 05 - 232818 (GIMA 24465)

by Sterilance Medical (Suzhou) Inc.

Identity

Device Name
Disposable Safety Lancets EUDAMED
Model / Reference
05 - 232818 (GIMA 24465) EUDAMED

Identifiers

Primary DI / UDI-DI
16945630119566 EUDAMED
Basic UDI-DI
6945630105BH EUDAMED
Unit of Use DI
06945630119569 EUDAMED
EMDN Code
V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Blood lancet, single-use

Disposable Safety Lancets by Sterilance Medical (Suzhou) Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Blood lancet, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000002860
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 75e9efc1-7c59-4bf2-9182-73f801d39f98 61 fields · synced Jun 18, 2026