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Silikon Gastrostomi Tüpü (Standard Tip)
EUDAMEDClass IIb (EU MDR)
Ref 800 000 1986Ref 800 000 1987Ref 002 265 0140Ref 800 000 1985
Identity
- Trade Name
- Silikon Gastrostomi Tüpü (Standard Tip) EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 800 000 1986 EUDAMED800 000 1987 EUDAMED002 265 0140 EUDAMED800 000 1985 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187222920 EUDAMED04542187222937 EUDAMED04542187222883 EUDAMED04542187222913 EUDAMED
- Basic UDI-DI
- 45421870000893 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Silikon Gastrostomi Tüpü (Standard Tip) by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy tube.
- 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
- Kangaroo — Cardinalhealth · Class II
- Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- EndoVive™ Low Profile Replacement Button — Boston Scientific · 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 (4)
- EUDAMED 80497cca-0831-4740-8dbd-fdce8bf4d767 61 fields · synced Aug 3, 2026
- EUDAMED 072dd07a-08e8-48d5-9223-23eae52d5824 61 fields · synced May 17, 2026
- EUDAMED bcbe0d09-a60d-4924-8823-a4a302d05845 61 fields · synced May 18, 2026
- EUDAMED 43f00ecb-39d0-4c6a-a3bb-ac526000a24f 61 fields · synced May 19, 2026