Disposable Automatically Retractable Safety Syringe (with fixed needle)

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref SSFN05-21-03Model 0.5ml 1ml 3ml 5ml 10ml 20ml

by Shantou Wealy Medical Instrument Co., Ltd.

Identity

Trade Name: Disposable Automatically Retractable Safety Syringe (with fixed needle) EUDAMED
Device Name: Disposable Safety Syringes (with fixed needle) EUDAMED
Model / Reference: 0.5ml 1ml 3ml 5ml 10ml 20ml EUDAMED
SSFN05-21-03 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971603581712 EUDAMED
Basic UDI-DI: 697160358WDSSQ6 EUDAMED
EMDN Code: A02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Disposable Automatically Retractable Safety Syringe (with fixed needle) by Shantou Wealy Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K141640	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K113587	Class IIa	Active
EUDAMED	European Union	CE/MDR	697160358WDSSQ6	Class IIa	Active

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Manufacturer

Manufacturer: Shantou Wealy Medical Instrument Co., Ltd.
EUDAMED SRN: CN-MF-000020619
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (2)

EUDAMED 7b5a58cd-adb0-45fd-b864-58456f6f4f38 61 fields · synced Oct 7, 2026
FDA 510(k) K141640 1 fields · synced May 18, 2026