Identity
- Trade Name
- TRUS Biopsy Kit EUDAMED
- Device Name
- TRUS Biopsy Kit EUDAMED
- Model / Reference
- TRUS Biopsy Kit EUDAMEDGTR-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683255239900 EUDAMED
- Basic UDI-DI
- 869915834GTRZ8 EUDAMED
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Used for USG guided Transrectal Prostate Biopsy for diagnosis. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Needle guide, single-use
TRUS Biopsy Kit by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 869915834GTRZ8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti
- EUDAMED SRN
- TR-PR-000039085
Sources (1)
- EUDAMED eb461306-14e4-4fc8-a13f-cd8d383fe468 61 fields · synced Jun 20, 2026