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All Silicone Gastrostomy Balloon Catheter (Standard Type)
EUDAMEDClass IIb (EU MDR)
Ref EN002-265-0140Ref 800 000 1987Ref EN002-265-0180Ref EN800-000-1987Ref 800 000 1985Ref 002 265 0120Ref 002 265 0160Ref EN002-265-0120Ref 002 265 0180
Identity
- Trade Name
- All Silicone Gastrostomy Balloon Catheter (Standard Type) EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- EN002-265-0140 EUDAMED800 000 1987 EUDAMEDEN002-265-0180 EUDAMEDEN800-000-1987 EUDAMED800 000 1985 EUDAMED002 265 0120 EUDAMED002 265 0160 EUDAMEDEN002-265-0120 EUDAMED002 265 0180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187216349 EUDAMED04542187212143 EUDAMED04542187216363 EUDAMED04542187216394 EUDAMED04542187212129 EUDAMED04542187212082 EUDAMED04542187229080 EUDAMED04542187216332 EUDAMED04542187212112 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 (Standard 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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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 (9)
- EUDAMED 58aa36b8-3e30-4f91-8a45-00f32e294055 61 fields · synced Jul 29, 2026
- EUDAMED a9210c2d-6d58-436f-9b90-34001321ad59 61 fields · synced May 16, 2026
- EUDAMED 39a5d7d0-96a4-4389-be42-20ab252e7086 61 fields · synced May 16, 2026
- EUDAMED 703fb72c-c723-46e2-9ce8-7fa22403de26 61 fields · synced May 17, 2026
- EUDAMED d8a9ec78-9f7c-4c85-a3c7-0b7eb8fe6f2a 61 fields · synced May 17, 2026
- EUDAMED 60c69f92-37b7-4229-80bd-cea3189cab52 61 fields · synced May 18, 2026
- EUDAMED 316a7536-ee73-4cba-b8c4-595071254fa1 61 fields · synced May 19, 2026
- EUDAMED bb20d09c-8be9-45c5-b93f-c5f0384e0a17 61 fields · synced May 19, 2026
- EUDAMED 37f62eb3-887b-423b-8534-3452ba4aecc2 61 fields · synced May 19, 2026