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Guang An Men

EUDAMED

Class IIa (EU MDR)

Ref PL3-030×40Model 0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mm

by Changchun AiK Medical Devices Co., Ltd.

Identity

Trade Name
Guang An Men EUDAMED
Device Name
Sterile Acupuncture Needles for Single Use EUDAMED
Model / Reference
0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mm EUDAMED
PL3-030×40 EUDAMED

Identifiers

Primary DI / UDI-DI
06977427145413 EUDAMED
Basic UDI-DI
697168527ZJZ004WW EUDAMED
EMDN Code
A019002 ACUPUNCTURE NEEDLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

Guang An Men by Changchun AiK Medical Devices 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
Changchun AiK Medical Devices Co., Ltd.
EUDAMED SRN
CN-MF-000026736
Authorised Representative
Llins Service & Consulting GmbH DE-AR-000009077

Sources (1)

  • EUDAMED 06d85139-4d34-4e58-99d6-f724940ece9b 61 fields · synced Jun 18, 2026