Solofix Safety

by HTL-Strefa S.A. 3 variants

Ref 7131Model Type 553-556, type 553-556

Active European Union

CE MDR CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	Number5907996095535563D Basic UDI-DI 05903999603304UDI-DI	Date3 Dec 2025Registered	StatusActive
European Union	CE/MDR	Number5907996095535563D Basic UDI-DI 05903999603304UDI-DI	Date3 Dec 2025Registered	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Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Device Name: Safety lancet
Model / Reference: Type 553-556, 7131

Primary DI / UDI-DI: 05903999603304
Basic UDI-DI: 5907996095535563D, B-05903999603304
EMDN Code: V010401 Lancets with safety systems, single-use

Device Class: Class IIa
EU market of registration: Denmark

Manufacturer details

EUDAMED SRN: PL-MF-000002198

Other devices from Htl Strefa S a

Clickfine

Class IIa
Haemolance Plus

Class IIa
droplet

Class IIa
droplet ULTIMATE

Class IIa
Medlance Plus, safety lancet

Class IIa
FreeStyle

Class IIa

See all devices from Htl Strefa S a →

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