Disposable Automatically Retractable Insulin Safety Syringe

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref SSFN01L-29-02Model 0.3ml 0.5ml 1ml

by Shantou Wealy Medical Instrument Co., Ltd.

Identity

Trade Name: Disposable Automatically Retractable Insulin Safety Syringe EUDAMED
Device Name: Disposable Insulin Safety Syringes EUDAMED
Model / Reference: 0.3ml 0.5ml 1ml EUDAMED
SSFN01L-29-02 EUDAMED

Identifiers

Primary DI / UDI-DI: 06971603582528 EUDAMED
Basic UDI-DI: 697160358WDISSQQ EUDAMED
EMDN Code: A0201060301 INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Greece 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 Insulin Safety Syringe by Shantou Wealy Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…

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	K191490	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K210216	Class IIa	Active
EUDAMED	European Union	CE/MDR	697160358WDISSQQ	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 cf88164e-863a-4f33-8f39-1aa244945998 61 fields · synced Oct 6, 2026
FDA 510(k) K191490 1 fields · synced May 18, 2026