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Disposable Blood Lancets

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 33GModel Model:30GRef 28G

by Suzhou Kyuan Medical Apparatus Co., Ltd

Identity

Trade Name
Disposable Blood Lancets EUDAMED
Device Name
Disposable Blood Lancets EUDAMED
Model / Reference
Model:30G EUDAMED
33G EUDAMED
28G EUDAMED

Identifiers

Primary DI / UDI-DI
16971517660258 EUDAMED
16971517661811 EUDAMED
16971517662276 EUDAMED
Basic UDI-DI
697151766bloodlancets116M EUDAMED
Direct Marketing DI
16971517660258 EUDAMED
16971517661811 EUDAMED
16971517662276 EUDAMED
EMDN Code
V010402 LANCETS WITHOUT 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

Disposable Blood Lancets by Suzhou Kyuan Medical Apparatus Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Suzhou Kyuan Medical Apparatus Co., Ltd
EUDAMED SRN
CN-MF-000021229
Authorised Representative
Llins Service & Consulting GmbH DE-AR-000009077

Sources (4)

  • EUDAMED fdf7dd8f-f2f1-4b16-942b-a91ba4fb8070 61 fields · synced Oct 5, 2026
  • EUDAMED 5fe7e201-79a8-4890-a710-611193abf03a 61 fields · synced May 16, 2026
  • EUDAMED d2e72dcb-cc0e-4b6a-886f-ba83b1a35cb1 61 fields · synced May 18, 2026
  • FDA 510(k) K220387 1 fields · synced May 18, 2026