Pulse
Ref 2040002Model Arrays, Single-Use
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0887517ARRAY2P 00195377099921 | Date1 Jun 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Arrays, Single-Use
- Model / Reference
- Arrays, Single-Use, 2040002
- Primary DI / UDI-DI
- 00195377099921
- Basic UDI-DI
- 0887517ARRAY2P
- Direct Marketing DI
- 00195377099921
- EMDN Code
- Z12011485 Surgical navigation instruments - consumables
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000007421
- Authorised representative
- AJW Technology Consulting GmbH DE-AR-000004999
Other devices from Nuvasive, Inc.
Properties
Other properties (12)
- 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