Viking™ M0044000050
Ref M0044000050
Active
CE MDR
Valid until
13 Nov 2029
FDA recalls
Not checked
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | NumberMDR 785454 | Date10 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08714729878056 | Date24 Sep 2016 | StatusListed |
Certificates
- MDR 785454 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 10 Jul 2026
- Expires
- 13 Nov 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Viking™
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use
- Device Name
- Viking
- Model / Reference
- M0044000050
- Primary DI / UDI-DI
- 08714729878056
- Basic UDI-DI
- 01915060000000000000430MV
- FDA Product Code
- DRF
- EMDN Code
- C020599 Cardiac diagnostic devices - other
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 870.1220
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Other devices from Boston Scientific
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