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Silicone Stomach Tube
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 2020-0006Ref 2020-0018Ref 2020-0012
Identity
- Trade Name
- Silicone Stomach Tube EUDAMEDFDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Silicone Stomach Tube EUDAMED
- Model / Reference
- 2020-0006 EUDAMEDFDA UDI2020-0018 EUDAMED2020-0012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961936336 EUDAMEDFDA UDI14710961936395 EUDAMED14710961936364 EUDAMED
- Basic UDI-DI
- B-04710961936336 EUDAMEDB-14710961936395 EUDAMEDB-14710961936364 EUDAMED
- 510(k) Number
- K022112 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G02020101 NASOGASTRIC TUBES EUDAMED
- GMDN Term
- Nasogastric feeding tube FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Malta EUDAMEDItaly EUDAMEDDenmark 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
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
Yes
FDA UDI
Silicone Stomach Tube by Fortune Medical Instrument Corp. — Class IIb — 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-04710961936336 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 914e9b58-2dc0-40d7-b54a-6e2e8bdba6a4 61 fields · synced Jul 25, 2026
- EUDAMED 87ab7796-2def-4552-80ab-a12b183b3792 61 fields · synced May 17, 2026
- EUDAMED efa93f3c-6a40-442e-bf3c-4060ebf328ed 61 fields · synced May 17, 2026
- FDA UDI b7caece8-4ebe-4c51-9618-09afff9ad9c4 33 fields · synced May 30, 2026