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Silicone Gastric Tube with ENFit Connector
EUDAMEDClass IIb (EU MDR)
Ref 2020-0514Ref 2020-0516Ref 2020-0518
Identity
- Trade Name
- Silicone Gastric Tube with ENFit Connector EUDAMED
- Device Name
- Silicone Gastric Tube with ENFit Connector EUDAMED
- Model / Reference
- 2020-0514 EUDAMED2020-0516 EUDAMED2020-0518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182607937 EUDAMED04711182607944 EUDAMED04711182607951 EUDAMED
- Basic UDI-DI
- B-04711182607937 EUDAMEDB-04711182607944 EUDAMEDB-04711182607951 EUDAMED
- EMDN Code
- G02020101 NASOGASTRIC TUBES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMEDDenmark EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Silicone Gastric Tube with ENFit Connector by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182607937 | Class IIb | Active |
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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 (3)
- EUDAMED a05f81df-eb48-457c-841f-47ea108cceba 61 fields · synced Oct 6, 2026
- EUDAMED 0729a04a-0bf3-4207-8130-364e4caaa1cf 61 fields · synced May 17, 2026
- EUDAMED 6d264471-7f88-43c7-a36c-ccc8d8c6da42 61 fields · synced May 18, 2026