OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 46cm Tubing

EUDAMED

Class IIa (EU MDR)

Ref OPT12609—46Q10

by EMED Technologies Corporation

Identity

Trade Name: OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 46cm Tubing EUDAMED
Device Name: OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 46cm Tubing with safety mechanism EUDAMED
Model / Reference: OPT12609—46Q10 EUDAMED

Identifiers

Primary DI / UDI-DI: 10817708023418 EUDAMED
Basic UDI-DI: B-10817708023418 EUDAMED
EMDN Code: Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED

Classification

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

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 46cm Tubing by EMED Technologies Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-10817708023418	Class IIa	Active

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Manufacturer

Manufacturer: EMED Technologies Corporation
EUDAMED SRN: US-MF-000012148
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED ddcb74ae-d915-42ad-bb88-2f44d7d40f16 61 fields · synced Jun 19, 2026