TRUS Biopsy Kit
by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti 300 variants
Ref GTR-DModel TRUS Biopsy Kit
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 | Number869915834GTRZ8 08683255239924 | Date25 Jul 2024 | 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- Withdrawn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
- Model / Reference
- TRUS Biopsy Kit, GTR-D
- Primary DI / UDI-DI
- 08683255239924
- Basic UDI-DI
- 869915834GTRZ8
- EMDN Code
- A010299 Biopsy needles and kits - other
- Device Class
- Class IIa
- Medical Purpose
- Used for USG guided Transrectal Prostate Biopsy for diagnosis.
Manufacturer details
- EUDAMED SRN
- TR-PR-000039085
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