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Sterile Stone Extraction Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref GF135716T
Identity
- Trade Name
- Sterile Stone Extraction Balloon Catheter EUDAMED
- Device Name
- Sterile Stone Extraction Balloon Catheter EUDAMED
- Model / Reference
- GF135716T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051302833 EUDAMED
- Basic UDI-DI
- 54200513-TF13-XTB-SU-MM EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
Yes
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
Sterile Stone Extraction Balloon Catheter by G-Flex Flexible Instruments Europe — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Stone Extraction Balloon
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 | 54200513-TF13-XTB-SU-MM | Class IIa | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (1)
- EUDAMED 3e78c58f-6f53-4c36-9c59-a6c31ce851f9 61 fields · synced Jun 19, 2026