Identity
- Trade Name
- NeutrArt EUDAMEDNeutrArt® FDA UDI
- Generic Name
- Neutral-pressure intravenous line needleless valve-connector FDA UDI
- Device Name
- Needle-Free Valve Neutral EUDAMEDNeedle-Free Neutral Valve FDA UDI
- Model / Reference
- Needle-free valve EUDAMEDA1010N EUDAMEDFDA UDI
- Description
- Needle-Free Neutral Valve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08699443581218 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08699443581218 EUDAMED
- 510(k) Number
- K201872 FDA UDI
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
- GMDN Term
- Neutral-pressure intravenous line needleless valve-connector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08699443581218 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- TR-MF-000018584
Sources (2)
- EUDAMED ff529e80-f99e-4416-be7f-356b26845232 61 fields · synced Oct 6, 2026
- FDA UDI d3fdbbd3-429a-4f0d-999c-c13adf0bd718 36 fields · synced May 30, 2026