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Siringa enterale 20 ml - NUTRIFIT
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1015.207
Identity
- Trade Name
- Siringa enterale 20 ml - NUTRIFIT EUDAMEDNUTRIFIT FDA UDI
- Generic Name
- ENFit oral/enteral syringe, single-use FDA UDI
- Device Name
- SIRINGHE ENTERALI PER POMPA E KIT PER ALIMENTAZIONE ENTERALE EUDAMEDEnteral ENFit syringe 20ml FDA UDI
- Model / Reference
- 1015.207 EUDAMEDFDA UDI
- Description
- Enteral ENFit syringe 20ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08015262020118 EUDAMEDFDA UDI
- Basic UDI-DI
- 80152621054W EUDAMED
- 510(k) Number
- K161141 FDA UDI
- FDA Product Code
- PNR FDA UDI
- EMDN Code
- A020108 ENTERAL FEEDING SYRINGES EUDAMED
- GMDN Term
- ENFit oral/enteral syringe, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
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
Siringa enterale 20 ml - NUTRIFIT by Pentaferte Italia Srl — Class IIa — 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 | 80152621054W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Pentaferte Italia Srl
- EUDAMED SRN
- IT-MF-000040982
Sources (2)
- EUDAMED 83a5a647-8718-42cb-8a2a-5893f26f455a 61 fields · synced Jun 18, 2026
- FDA UDI df30c51b-1607-47a4-8f07-32633654a34b 34 fields · synced May 30, 2026