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Sansin

EUDAMED

Class IIa (EU MDR)

Ref Type A 1.4mm (17G)Model Type A 1.8mm (15G)、 Type A 1.6mm (16G)、 Type A 1.4mm (17G)、 Type A 1.2mm (18G)、 Type B 1.8mm (15G)、 Type B 1.6mm (16G)、 Type B 1.4mm (17G)、 Type B 1.2mm (18G)etc

by Jiangxi Sanxin Medtec Co., Ltd.

Identity

Trade Name
Sansin EUDAMED
Device Name
A.V. Fistula Needle Sets EUDAMED
Model / Reference
Type A 1.8mm (15G)、 Type A 1.6mm (16G)、 Type A 1.4mm (17G)、 Type A 1.2mm (18G)、 Type B 1.8mm (15G)、 Type B 1.6mm (16G)、 Type B 1.4mm (17G)、 Type B 1.2mm (18G)etc EUDAMED
Type A 1.4mm (17G) EUDAMED

Identifiers

Primary DI / UDI-DI
06945060591904 EUDAMED
Basic UDI-DI
69450605SX009PY EUDAMED
EMDN Code
A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Bulgaria 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

Sansin by Jiangxi Sanxin Medtec 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
Jiangxi Sanxin Medtec Co., Ltd.
EUDAMED SRN
CN-MF-000018456
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED 93ee1fea-ea86-4bba-aa16-dbb726ae097d 61 fields · synced May 23, 2026