Calbreak
by SWL Medizin GmbH 13 variants
Part of a family of 13 devices: see the family page
Ref 835536
Calbreak (835536) is a Class III device made by SWL Medizin GmbH, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 42517902VBCVE) with CE/MDR certificate MDR.2292-2026/0008 valid until 11 Mar 2031, active as of 22 Oct 2026.
Active
CE MDR
Valid until
11 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42517902VBCVE 04251790255361 | Date16 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 42517902VBCVE
Certificates
- MDR.2292-2026/0008 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 12 Mar 2026
- Expires
- 11 Mar 2031
Timeline
- Certificate issued EUDAMED MDR.2292-2026/0008
- Registered EUDAMED 42517902VBCVE
- Certificate expires EUDAMED MDR.2292-2026/0008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Coronary Cutting Balloon Dilatation Catheter
- Model / reference
- 835536
- Primary DI / UDI-DI
- 04251790255361
- Basic UDI-DI
- 42517902VBCVE
- EMDN code
- C010401020101 Ptca balloon dilation catheters
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- DE-MF-000008000
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