Irreversible Electroporation Probe
by Zhejiang CuraWay Medical Technology Co., Ltd. 15 variants
Ref CNBT1815-40, CNST1915A, CNBT1815-10, CNST1915, CNBT1815-30, CNST1913A, CNBT1515-10, CNBT1525-30, CNBT1515-40, CNBT1825-20
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number16936666501159 | Date31 May 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number69366665NKJF | Date13 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Curaway
- Generic Name
- Irreversible electroporation system
- Model / Reference
- CNBT1815-40, CNST1915A, CNBT1815-10, CNST1915, CNBT1815-30, CNST1913A, CNBT1515-10, CNBT1525-30, CNBT1515-40, CNBT1825-20
- Primary DI / UDI-DI
- 16936666501159 EUDAMED16936666501333 EUDAMED16936666501180 EUDAMED16936666501296 EUDAMED16936666501166 EUDAMED16936666501340 EUDAMED16936666501265 EUDAMED16936666501203 EUDAMED16936666501234 EUDAMED16936666501135 EUDAMED16937278652147 GUDID16937278652123 GUDID16936666558139 GUDID16936666558122 GUDID16936666558115 GUDID16936666558023 GUDID16936666558061 GUDID16936666558047 GUDID16936666558016 GUDID16936666557972 GUDID
- Basic UDI-DI
- 69366665NKJF
- 510(k) Number
- FDA Product Code
- OAB
- EMDN Code
- K02010199 Mono- and bipolar instruments, single-use - other
- GMDN Term
- Irreversible electroporation system
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4400
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 16936666501159 16936666501333 16936666501180 16936666501296 16936666501166 16936666501340 16936666501265 16936666501203 16936666501234 16936666501135 | 16937278652147 16937278652123 16936666558139 16936666558122 16936666558115 16936666558023 16936666558061 16936666558047 16936666558016 16936666557972 |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000025983
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Zhejiang CuraWay Medical Technology Co., Ltd.
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Properties
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No