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Purfit Gastrostomy Button 16fr 3.5 Cm Pgb16-3.5
EUDAMEDClass IIb (EU MDR)
Ref PGB16-3.5Model PURFIT GASTROSTOMY BUTTON 14FR 3CM PGB14-3.0
Identity
- Trade Name
- PURFIT GASTROSTOMY BUTTON 16FR 3.5 CM PGB16-3.5 EUDAMED
- Device Name
- PURFIT GASTROSTOMY BUTTON 14FR 3CM PGB14-3.0 EUDAMED
- Model / Reference
- PURFIT GASTROSTOMY BUTTON 14FR 3CM PGB14-3.0 EUDAMEDPGB16-3.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760348111086 EUDAMED
- Basic UDI-DI
- 376034811100.01AT EUDAMED
- Direct Marketing DI
- 03760348111086 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastrostomy tube
Purfit Gastrostomy Button 16fr 3.5 Cm Pgb16-3.5 by Hoist Medical — 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
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection — Xeridiem Medical Devices · Class II
- AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
- 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 | 376034811100.01AT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hoist Medical
- EUDAMED SRN
- FR-MF-000026140
Sources (1)
- EUDAMED c1d1ef11-cf43-4104-8e36-293fc5b4f1e1 61 fields · synced Jun 18, 2026