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Sonda de Gastrostomia em Silicone com balão (tipo padrão)
EUDAMEDClass IIb (EU MDR)
Ref 002-265-0140Ref 800-000-1985Ref 002-265-0160Ref 002-265-0180Ref 002-265-0120
Identity
- Trade Name
- Sonda de Gastrostomia em Silicone com balão (tipo padrão) EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 002-265-0140 EUDAMED800-000-1985 EUDAMED002-265-0160 EUDAMED002-265-0180 EUDAMED002-265-0120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899780123114 EUDAMED07899780123145 EUDAMED07899780123121 EUDAMED07899780123138 EUDAMED07899780123107 EUDAMED
- Basic UDI-DI
- 45421870000893 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb 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
Sonda de Gastrostomia em Silicone com balão (tipo padrão) by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
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- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
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- AVANOS — Avanos Medical, Inc. · Class II
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
- Kangaroo — Cardinalhealth · Class II
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 | 45421870000893 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED b1a69998-33b8-40b3-85d8-5b29112e26de 61 fields · synced Oct 6, 2026
- EUDAMED 72e6f8a1-c50e-4111-991b-304a0b2b1709 61 fields · synced May 18, 2026
- EUDAMED 68471a2b-57a9-4de7-a41b-560a10101316 61 fields · synced May 18, 2026
- EUDAMED 3d0909e1-9c74-4652-86ed-2c49ed0748de 61 fields · synced May 18, 2026
- EUDAMED 1c7b6142-8eb6-4673-be3c-cff77954b3a9 61 fields · synced May 18, 2026