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All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type)
EUDAMEDClass IIb (EU MDR)
Ref 800 000 2168
Identity
- Trade Name
- All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 800 000 2168 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187229196 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
All Silicone Gastrostomy Balloon Catheter (Flat Balloon Type) by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED e4a6a1ed-8ddb-4f71-9ac3-5779734d5ebd 61 fields · synced Oct 5, 2026