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NeutrArt

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref A3010NModel Extension sets

by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi

Identity

Trade Name
NeutrArt EUDAMED
NeutrArt® FDA UDI
Generic Name
Neutral-pressure intravenous line needleless valve-connector FDA UDI
Device Name
Triple Lumen Needle-Free Valve Neutral EUDAMED
Triple Lumen Extension Set w/Bonded Needle-Free Neutral Valve FDA UDI
Model / Reference
Extension sets EUDAMED
A3010N EUDAMEDFDA UDI
Description
Triple Lumen Extension Set w/Bonded Needle-Free Neutral Valve FDA UDI

Identifiers

Primary DI / UDI-DI
08699443581553 EUDAMEDFDA UDI
Basic UDI-DI
B-08699443581553 EUDAMED
510(k) Number
K201872 FDA UDI
FDA Product Code
FPA FDA UDI
EMDN Code
A03020199 EXTENSIONS - OTHER EUDAMED
GMDN Term
Neutral-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

NeutrArt 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 0e812d74-9fd5-4d66-b0a6-11ce844a618b 61 fields · synced Oct 6, 2026
  • FDA UDI cce037d1-f1d5-4bce-8544-eb9f23ec3355 36 fields · synced May 30, 2026