Trenza
by Stryker Neurovascular 7 variants
Ref IST00E0916Model 08858250000268RX
Active
CE MDR
Valid until
24 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08858250000268RX 07613327469516 | Date21 Sep 2026 | StatusActive |
Certificates
- MDR 829526 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 25 Jun 2026
- Expires
- 24 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Trenza Embolization Device
- Model / Reference
- 08858250000268RX, IST00E0916
- Primary DI / UDI-DI
- 07613327469516
- Basic UDI-DI
- 08858250000268RX
- EMDN Code
- C010404020201 Neurovascular embolisation coils
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002456
- Authorised representative
- Stryker European Operations Limited IE-AR-000000092
Other devices from Stryker Neurovascular
Properties
Other properties (11)
- 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