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TRUS Biopsy Kit
EUDAMEDClass IIa (EU MDR)
Ref GTR-CModel TRUS Biopsy KitRef GTR-GRef GTR-HRef GTR-ERef GTR-FRef GTR-K Ref GTR-ARef GTR H18Ref GTR B11Ref GTR K15Ref GTR K152
Identity
- Trade Name
- TRUS Biopsy Kit EUDAMED
- Device Name
- TRUS Biopsy Kit EUDAMED
- Model / Reference
- TRUS Biopsy Kit EUDAMEDGTR-C EUDAMEDGTR-G EUDAMEDGTR-H EUDAMEDGTR-E EUDAMEDGTR-F EUDAMEDGTR-K EUDAMEDGTR-A EUDAMEDGTR H18 EUDAMEDGTR B11 EUDAMEDGTR K15 EUDAMEDGTR K152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683255239917 EUDAMED08683255239955 EUDAMED08681672053574 EUDAMED08683255239931 EUDAMED08683255239948 EUDAMED08681672053598 EUDAMED08683255239894 EUDAMED08681672058852 EUDAMED08681672056995 EUDAMED08681672059439 EUDAMED08681672059606 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.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
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- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 (11)
- EUDAMED 8fffc4dd-b509-4170-b458-16a9038fb391 61 fields · synced Sep 30, 2026
- EUDAMED 537145f5-999b-49f3-8efd-2fde331e856d 61 fields · synced May 17, 2026
- EUDAMED 4fea1cc6-09e3-4482-ad35-6859a3e1153a 61 fields · synced May 17, 2026
- EUDAMED e9663a21-5b23-4bd5-8b58-9f027d520ec3 61 fields · synced May 17, 2026
- EUDAMED aad0af30-266d-4be5-ad92-3032382cd51c 61 fields · synced May 18, 2026
- EUDAMED 0ab9e261-2e6d-491b-acff-e88eb7886dbb 61 fields · synced May 18, 2026
- EUDAMED 2f197227-4fd4-473e-9c26-24b5b011e9ee 61 fields · synced May 19, 2026
- EUDAMED c1dfa859-dd4b-4d05-a107-ab08ca33700d 61 fields · synced Aug 1, 2026
- EUDAMED a8b93e0c-0aa5-4a48-beb9-f3377742fc28 61 fields · synced Aug 1, 2026
- EUDAMED 1c3058ff-12c3-42f0-a89e-71a27dee5849 61 fields · synced Sep 30, 2026
- EUDAMED bbf18902-49a2-4dd2-85f6-4eb9815a67e2 61 fields · synced Sep 30, 2026