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Silicone Gastric Tube, Detachable Type
EUDAMEDClass IIb (EU MDR)
Ref 2020-7016Ref 2020-6516Ref 2020-7516
Identity
- Trade Name
- Silicone Gastric Tube, Detachable Type EUDAMED
- Device Name
- Silicone Gastric Tube, Detachable Type EUDAMED
- Model / Reference
- 2020-7016 EUDAMED2020-6516 EUDAMED2020-7516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182628888 EUDAMED14711182606449 EUDAMED04711182606442 EUDAMED04711182628871 EUDAMED
- Basic UDI-DI
- B-04711182628888 EUDAMEDB-14711182606449 EUDAMEDB-04711182606442 EUDAMEDB-04711182628871 EUDAMED
- EMDN Code
- G02020101 NASOGASTRIC TUBES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDFinland 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, Detachable Type 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-04711182628888 | 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 (4)
- EUDAMED 858a83ff-1e0e-4ffe-9286-7fcd112e4318 61 fields · synced Sep 17, 2026
- EUDAMED 1652509f-eb95-444d-aa9e-48590c589e2e 61 fields · synced May 18, 2026
- EUDAMED 9306a5e5-a9b4-4565-923a-c018da54ca51 61 fields · synced May 18, 2026
- EUDAMED 094f3c7f-42ba-43fa-9cf7-00b202d73981 61 fields · synced May 18, 2026