EXEL SecureTouch Safety Hypodermic Needle 25G x 5/8"

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 27403

by Exelint International, Co.

Identity

Trade Name: EXEL SecureTouch Safety Hypodermic Needle 25G x 5/8" EUDAMED
Device Name: Safety Needle EUDAMED
EXEL SecureTouch Safety Hypodermic Needle EUDAMED
Model / Reference: 27403 EUDAMED

Identifiers

Primary DI / UDI-DI: 00020221274035 EUDAMED
Basic UDI-DI: B-00020221274035 EUDAMED
20221HYPOSFT2742N EUDAMED
EMDN Code: A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Netherlands EUDAMED
Austria 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

EUDAMED

Incorporates Medicinal Product

EUDAMED

EXEL SecureTouch Safety Hypodermic Needle 25G x 5/8" by Exelint International, Co. — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K152183	Class IIa	Active
EUDAMED	European Union	CE/MDR	B-00020221274035	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-00020221274035	Class IIa	Active

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Manufacturer

Manufacturer: Exelint International, Co.
EUDAMED SRN: US-MF-000037396
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED da8f5482-48f1-4eef-a7db-b7a2d3bef592 61 fields · synced Jul 10, 2026
EUDAMED 3050d72f-33ba-455d-a0bc-571af5bba69a 61 fields · synced May 16, 2026
FDA 510(k) K152183 1 fields · synced May 18, 2026