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All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type)
EUDAMEDClass IIb (EU MDR)
Ref 800 000 2167Ref 800 000 2162Ref 800 000 2166Ref 800 000 2163Ref 800 000 2165
Identity
- Trade Name
- All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 800 000 2167 EUDAMED800 000 2162 EUDAMED800 000 2166 EUDAMED800 000 2163 EUDAMED800 000 2165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187229189 EUDAMED04542187229134 EUDAMED04542187229172 EUDAMED04542187229141 EUDAMED04542187229165 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
All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastrostomy tube.
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- AVANOS — Avanos Medical, Inc. · Class II
- Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
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- 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 861f77fe-757c-47b2-b405-fdb609530c04 61 fields · synced Oct 6, 2026
- EUDAMED 447462cf-101f-402e-bec4-76d5c07bd570 61 fields · synced May 16, 2026
- EUDAMED ea903be3-9296-4b5b-b053-2f953ce53fe3 61 fields · synced May 16, 2026
- EUDAMED b5518284-bc09-424e-9ee5-504bdec8f0ad 61 fields · synced May 16, 2026
- EUDAMED 94c59df8-ad12-4fb7-a1fb-8fcbff7c0f74 61 fields · synced May 18, 2026