Locaste
by Hangzhou LEEKAI Technology Co., Ltd 12 variants
Ref PICA8F80MPSModel PICA8F80S PICA8FG80S PICA8F80MPS PICA8FG80MPS PICA8F90S PICA8FG90S PICA8F90MPS PICA8FG90MPS PICA8F100S PICA8FG100S PICA8F100MPS PICA8FG100MPS
Active
CE MDR
Valid until
16 Dec 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69419030PICA8FM5 06941903006628 | Date12 Jan 2026 | StatusActive |
Certificates
- MDR 804468 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 17 Dec 2025
- Expires
- 16 Dec 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Locaste 8F Guiding Catheter
- Model / Reference
- PICA8F80S PICA8FG80S PICA8F80MPS PICA8FG80MPS PICA8F90S PICA8FG90S PICA8F90MPS PICA8FG90MPS PICA8F100S PICA8FG100S PICA8F100MPS PICA8FG100MPS, PICA8F80MPS
- Primary DI / UDI-DI
- 06941903006628
- Basic UDI-DI
- 69419030PICA8FM5
- EMDN Code
- C0104010202 Cardiac angiography guide catheters
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000039215
- Authorised representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Other devices from Hangzhou LEEKAI Technology Co., Ltd
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