FlowArt

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref AV4013Model IV Set Accessories

by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name: FlowArt EUDAMED
FlowArt® FDA UDI
Generic Name: Vial/bottle adaptor, non-hermetic FDA UDI
Device Name: Valve For Vial Access, 13 mm EUDAMED
Vial Access Device, 13 mm FDA UDI
Model / Reference: IV Set Accessories EUDAMED
AV4013 EUDAMEDFDA UDI
Description: Vial Access Device, 13 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 08699443580174 EUDAMEDFDA UDI
Basic UDI-DI: B-08699443580174 EUDAMED
510(k) Number: K232987 FDA UDI
FDA Product Code: LHI FDA UDI
EMDN Code: A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
GMDN Term: Vial/bottle adaptor, non-hermetic 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08699443580174	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

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

Sources (2)

EUDAMED 5456910f-d376-412d-9d0b-21b293f4994b 61 fields · synced Oct 6, 2026
FDA UDI 12fda293-6344-4ebd-913a-9b622e60b088 35 fields · synced May 30, 2026