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For Enteral Feeding only. For use with Extension Feeding Set with ENFit connect…
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref GH241210ME
Identity
- Trade Name
- For Enteral Feeding only. For use with Extension Feeding Set with ENFit connectors. It is highly recommended to consult the instructions before use EUDAMED
- Device Name
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit EUDAMED
- Model / Reference
- GH241210ME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18586026083504 EUDAMED
- Basic UDI-DI
- 602147GBUTTON5G EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastrostomy tube
For Enteral Feeding only. For use with Extension Feeding Set with ENFit connect… by Sky Medical a.s. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250481 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 602147GBUTTON5G | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sky Medical a.s.
- EUDAMED SRN
- SK-MF-000001475
Sources (2)
- EUDAMED ca5ce6ae-71da-4f87-ba0d-a00f3f093375 61 fields · synced Oct 8, 2026
- FDA 510(k) K250481 1 fields · synced May 18, 2026