Identity
- Trade Name
- Non-sterile Reusable Lithotripsy System EUDAMED
- Device Name
- Non-sterile Reusable Lithotripsy System EUDAMED
- Model / Reference
- 22640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051300204 EUDAMED
- Basic UDI-DI
- 54200513-TF07-BKT-RU-EA EUDAMED
- EMDN Code
- G0305010201 DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, REVOLVING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
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
Non-sterile Reusable Lithotripsy System by G-Flex Flexible Instruments Europe — Class I — 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 | 54200513-TF07-BKT-RU-EA | Class I | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (1)
- EUDAMED 096d1009-6beb-4483-88d9-aea80e5d7e58 61 fields · synced Jul 22, 2026