Identity
- Trade Name
- SENTINELplus EUDAMEDSentinelPLUS® FDA UDI
- Generic Name
- Enteral feeding pump FDA UDI
- Device Name
- SENTINELplus Enteral Feeding Pump EUDAMEDSentinelPLUS®, Enteral Feeding Pump FDA UDI
- Model / Reference
- S-3000-IU EUDAMEDFDA UDI
- Description
- SentinelPLUS®, Enteral Feeding Pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896406002591 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00896406002591 EUDAMED
- 510(k) Number
- K011587 FDA UDI
- FDA Product Code
- LZH FDA UDI
- EMDN Code
- Z12030303 ENTERAL FEEDING PUMPS EUDAMED
- GMDN Term
- Enteral feeding pump FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
EUDAMED
Measuring Function
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SENTINELplus by Alcor Scientific — 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-00896406002591 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Alcor Scientific
- EUDAMED SRN
- US-MF-000029295
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 584e6d48-b1c5-4cfb-aa5d-03e9f1483353 61 fields · synced May 30, 2026
- FDA UDI 2eb147ad-81d9-47a6-a20e-be4c4a684fcf 34 fields · synced May 30, 2026