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Disposable Safety Syringe (auto-disable)

EUDAMED

Class IIa (EU MDR)

Ref SSAD10Model 0.5ml 1ml 3ml 5ml 10ml

by Shantou Wealy Medical Instrument Co., Ltd.

Identity

Trade Name
Disposable Safety Syringe (auto-disable) EUDAMED
Device Name
Disposable Safety Syringe (auto-disable) EUDAMED
Model / Reference
0.5ml 1ml 3ml 5ml 10ml EUDAMED
SSAD10 EUDAMED

Identifiers

Primary DI / UDI-DI
06971603585468 EUDAMED
Basic UDI-DI
697160358WDSSADTG EUDAMED
EMDN Code
A02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Northern Ireland 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

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable Safety Syringe (auto-disable) by Shantou Wealy Medical Instrument 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

EUDAMED SRN
CN-MF-000020619
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED 9932d2b8-79ce-4fc3-97a2-de1b18c15b26 61 fields · synced Oct 7, 2026