Bialmed

by Jiangsu Kanghua Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref KM090X25FModel ZSZ-1~ZSZ-238

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberB-16935491700423 Basic UDI-DI	Date25 May 2026Registered	StatusActive
European Union	CE/MDD	NumberB-16935491700423 Basic UDI-DI	Date25 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Sterile Hypodermic Needles for Single Use
Model / Reference: KM090X25F, ZSZ-1~ZSZ-238

Primary DI / UDI-DI: 16935491700423, 06935491777176
Basic UDI-DI: B-16935491700423, 693549170400JW
EMDN Code: A0101010102 Hypodermic syringe needles, w/o safety systems

Device Class: Class IIa
Market of Registration: Greece
Poland

Manufacturer details

EUDAMED SRN: CN-MF-000033842
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Class I
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Bm

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See all devices from Jiangsu Kanghua Medical Equipment Co., Ltd. →

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