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All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type
EUDAMEDClass IIb (EU MDR)
Ref 800-000-2168Ref 800-000-2166Ref 800-000-2162Ref 800-000-2165
Identity
- Trade Name
- All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 800-000-2168 EUDAMED800-000-2166 EUDAMED800-000-2162 EUDAMED800-000-2165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187173338 EUDAMED04542187173314 EUDAMED04542187173277 EUDAMED04542187173307 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 for Replacement, Flat Balloon Type by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED
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Also classified as Gastrostomy tube.
- Balloon G-Tube — Applied Medical Technology, Inc. · Class II
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- 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 2dadaf65-7387-414f-b4a6-04f2158039b6 61 fields · synced Jul 13, 2026
- EUDAMED 75b43a70-525e-4705-983a-19e27018bd20 61 fields · synced May 17, 2026
- EUDAMED ac529c85-d055-44a1-9d29-6de2988087b6 61 fields · synced May 18, 2026
- EUDAMED 7e481ccc-d7df-4916-b2e6-bfee2819d02c 61 fields · synced May 19, 2026