Identity
- Trade Name
- Gastrostomy Tube and Accessories EUDAMED
- Device Name
- Gastrostomy Tube and Accessories EUDAMED
- Model / Reference
- PEG-18SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953676340540 EUDAMED
- Basic UDI-DI
- 69536763GTA001R4 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Gastrostomy Tube and Accessories by Hangzhou Fushan Medical Appliances 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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- AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · 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 | 69536763GTA001R4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hangzhou Fushan Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000022768
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 76dd0652-91b0-4eea-b257-090ee6fab025 61 fields · synced Jun 17, 2026