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Twist-off lancet (use with lancing device)

EUDAMED

Class IIa (EU MDR)

Ref NoModel I, II, III, V, VI, VII, VIII, IX

by Tianjin Huahong Technology Co., Ltd.

Identity

Device Name
Twist-off lancet (use with lancing device) EUDAMED
Model / Reference
I, II, III, V, VI, VII, VIII, IX EUDAMED
No EUDAMED

Identifiers

Primary DI / UDI-DI
06957138613906 EUDAMED
Basic UDI-DI
69571386TOL01YF EUDAMED
Unit of Use DI
56957138613901 EUDAMED
EMDN Code
V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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

Twist-off lancet (use with lancing device) by Tianjin Huahong Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Tianjin Huahong Technology Co., Ltd.
EUDAMED SRN
CN-MF-000015849
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 89cb6fcb-7529-44d5-8ee9-14fbfe503941 61 fields · synced Jun 18, 2026