Identity
- Trade Name
- Siringa enterale 1 ml- NUTRISAFE2 EUDAMEDVYGON FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- SIRINGHE E ACCESSORI ENTERALI EUDAMED1ML SYRINGE FOR SAFETY CONNECTION NUTRISAFE 2 VY-P FDA UDI
- Model / Reference
- 1015.014 EUDAMEDFDA UDI
- Description
- 1ML SYRINGE FOR SAFETY CONNECTION NUTRISAFE 2 VY-P FDA UDI
Identifiers
- Catalog Number
- 1015.014 FDA UDI
- Primary DI / UDI-DI
- 08015262022242 EUDAMEDFDA UDI
- Basic UDI-DI
- 80152621044U EUDAMED
- 510(k) Number
- K060944 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- A020108 ENTERAL FEEDING SYRINGES EUDAMED
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- France 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Siringa enterale 1 ml- NUTRISAFE2 by Pentaferte Italia Srl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80152621044U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pentaferte Italia Srl
- EUDAMED SRN
- IT-MF-000040982
Sources (2)
- EUDAMED 30161191-6804-4aae-9975-bd08a4daacef 61 fields · synced Jul 16, 2026
- FDA UDI 41b82119-3e1d-4607-957e-b9ea537a5627 35 fields · synced May 30, 2026