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FlowArt

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref ATU3010Model Extension sets

by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name
FlowArt EUDAMED
FlowArt® FDA UDI
Generic Name
Negative-pressure intravenous line needleless valve-connector FDA UDI
Device Name
Needle-Free Connector with Three Way Stopcock EUDAMED
Needle-Free Split Septum Valve with Three-Way Stopcock FDA UDI
Model / Reference
Extension sets EUDAMED
ATU3010 EUDAMED
ATU1010 FDA UDI
Description
Needle-Free Split Septum Valve with Three-Way Stopcock FDA UDI

Identifiers

Primary DI / UDI-DI
08699443584219 EUDAMEDFDA UDI
Basic UDI-DI
B-08699443584219 EUDAMED
510(k) Number
K190806 FDA UDI
FDA Product Code
FPA FDA UDI
EMDN Code
A03020199 EXTENSIONS - OTHER EUDAMED
GMDN Term
Negative-pressure intravenous line needleless valve-connector FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

FlowArt by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi
EUDAMED SRN
TR-MF-000018584

Sources (2)

  • EUDAMED c16a74bb-cd56-4b9f-afd9-e2ee24dda0f7 61 fields · synced Oct 10, 2026
  • FDA UDI 38ba1f84-2d09-48e8-8fe2-c247d180b9ba 36 fields · synced May 30, 2026