Identity
- Trade Name
- Calbreak EUDAMED
- Device Name
- Coronary Cutting Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 835538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790255385 EUDAMED
- Basic UDI-DI
- 42517902VBCVE EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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: Coronary angioplasty balloon catheter, cutting/scoring
Calbreak by SWL Medizin GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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- POT — BrosMed Medical Co., Ltd. · Class III
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 | 42517902VBCVE | Class III | Active |
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Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (1)
- EUDAMED 5594080c-6201-4983-9e5e-0c7da8674909 61 fields · synced Jun 19, 2026