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Peg Replacement With Enfit Connector
EUDAMEDClass IIb (EU MDR)
Ref 002-265-0160Ref 002-265-0120Ref 800-000-1986Ref 002-265-0140Ref 002-265-0180
Identity
- Trade Name
- PEG REPLACEMENT WITH ENFIT CONNECTOR EUDAMED
- Device Name
- All Silicone Gastrostomy Balloon Catheter EUDAMED
- Model / Reference
- 002-265-0160 EUDAMED002-265-0120 EUDAMED800-000-1986 EUDAMED002-265-0140 EUDAMED002-265-0180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187172638 EUDAMED04542187172614 EUDAMED04542187172669 EUDAMED04542187172621 EUDAMED04542187172645 EUDAMED
- Basic UDI-DI
- 45421870000893 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Peg Replacement With Enfit Connector 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 (5)
- EUDAMED e59a610c-22cc-432f-98de-61f7e1f31343 61 fields · synced Jul 24, 2026
- EUDAMED cd2e7d16-1320-432a-914e-9eb42ab03502 61 fields · synced May 17, 2026
- EUDAMED 5356310b-be95-47ba-9aff-873089e4b658 61 fields · synced May 17, 2026
- EUDAMED 14f5af5e-2942-44df-bf91-35028265ad9a 61 fields · synced May 18, 2026
- EUDAMED 877bd977-52bb-4225-b7b4-7b9d3d21b324 61 fields · synced May 19, 2026