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Low-Profile Gastrostomy Replacement Tube (G. Button) Kit
EUDAMEDClass IIb (EU MDR)
Ref GH201510ME
Identity
- Trade Name
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit EUDAMED
- Device Name
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit EUDAMED
- Model / Reference
- GH201510ME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18586021477049 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
Low-Profile Gastrostomy Replacement Tube (G. Button) Kit by Sky Medical a.s. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 6c900db1-66ff-4384-9a15-d53943c188d6 61 fields · synced Jun 18, 2026