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Silicone Gastrostomy Catheter
EUDAMEDClass IIb (EU MDR)
Ref 2019-0020Ref 2019-0018Ref 2019-0516Ref 2019-0014Ref 2019-0012Ref 2019-0518Ref 2019-0514Ref 2019-0022Ref 2019-0520Ref 2019-0016Ref 2015 seriesModel 2019 series
Identity
- Trade Name
- Silicone Gastrostomy Catheter EUDAMED
- Device Name
- Silicone Gastrostomy Catheter EUDAMED
- Model / Reference
- 2019-0020 EUDAMED2019-0018 EUDAMED2019-0516 EUDAMED2019-0014 EUDAMED2019-0012 EUDAMED2019-0518 EUDAMED2019-0514 EUDAMED2019-0022 EUDAMED2019-0520 EUDAMED2019-0016 EUDAMED2019 series EUDAMED2015 series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961936299 EUDAMED04710961936282 EUDAMED14710961936296 EUDAMED04711182608378 EUDAMED04710961936268 EUDAMED04710961936251 EUDAMED04711182608385 EUDAMED04711182608361 EUDAMED14710961936302 EUDAMED04711182608392 EUDAMED14710961936258 EUDAMED14710961936265 EUDAMED14710961936272 EUDAMED
- Basic UDI-DI
- B-04710961936299 EUDAMEDB-04710961936282 EUDAMEDB-14710961936296 EUDAMEDB-04711182608378 EUDAMEDB-04710961936268 EUDAMEDB-04710961936251 EUDAMEDB-04711182608385 EUDAMEDB-04711182608361 EUDAMEDB-14710961936302 EUDAMEDB-04711182608392 EUDAMEDB-14710961936258 EUDAMEDB-14710961936265 EUDAMEDB-14710961936272 EUDAMED471096193100702FR EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDDenmark EUDAMEDItaly EUDAMEDFinland EUDAMEDLithuania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastrostomy tube
Silicone Gastrostomy Catheter by Fortune Medical Instrument Corp. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastrostomy tube.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04710961936299 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04710961936299 | 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 (14)
- EUDAMED a3945089-5602-414d-a484-4313dccc8353 61 fields · synced Sep 18, 2026
- EUDAMED 6bc7f801-abf4-4818-abe0-4ada67de952d 61 fields · synced May 17, 2026
- EUDAMED 4f0983d2-ce58-42ce-a5b6-0ee916edca9c 61 fields · synced May 17, 2026
- EUDAMED 3a792a11-7342-4190-b321-f88888b79188 61 fields · synced May 17, 2026
- EUDAMED dedb5555-c77b-404e-abde-a436260646b5 61 fields · synced May 17, 2026
- EUDAMED c234e452-1466-4f94-afae-c753145c4d3e 61 fields · synced May 17, 2026
- EUDAMED 5ab4c0ae-5c8d-4a21-9db7-0662142fbed3 61 fields · synced May 17, 2026
- EUDAMED aa7e2bfe-076c-4584-918b-6ea88392bbb0 61 fields · synced May 17, 2026
- EUDAMED 9b2e90b5-5844-448c-98b9-d4def8320bbe 61 fields · synced May 18, 2026
- EUDAMED 3d582623-a0ca-4994-8e4d-54d10e77c4f3 61 fields · synced May 19, 2026
- EUDAMED 1a812c1d-9459-411b-b85b-390e940c03e6 61 fields · synced May 19, 2026
- EUDAMED 1e5f058b-9fc5-4481-ab04-c8ef6bc22b86 61 fields · synced May 19, 2026
- EUDAMED 7dacc9a6-e233-428e-8f1c-0115925248e2 61 fields · synced May 19, 2026
- EUDAMED e2f5814a-3ba6-42c2-9c44-43155401f687 61 fields · synced Jul 9, 2026