GimaLancet

by Sterilance Medical (Suzhou) Inc. 3 variants

Ref Press plus 21G 2.2mm

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number6945630105BH Basic UDI-DI 16945630136983UDI-DI	Date20 Feb 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Disposable Safety Lancets
Model / Reference: Press plus 21G 2.2mm

Primary DI / UDI-DI: 16945630136983
Basic UDI-DI: 6945630105BH
Unit of Use DI: 06945630136986
EMDN Code: V010401 Lancets with safety systems, single-use

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

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

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Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No