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Tumor Marker Needle with Preloaded PEEK Marker
EUDAMEDClass IIb (EU MDR)
Ref GTP1610Model Tumor Marker Needle
Identity
- Trade Name
- Tumor Marker Needle with Preloaded PEEK Marker EUDAMED
- Device Name
- Tumor Marker Needle w/PEEK Marker EUDAMED
- Model / Reference
- Tumor Marker Needle EUDAMEDGTP1610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681672052560 EUDAMED
- Basic UDI-DI
- 869915834GTPZ4 EUDAMED
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Needle guide, single-use
Tumor Marker Needle with Preloaded PEEK Marker by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti — Class IIb — MDR — listed in EUDAMED
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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 | 869915834GTPZ4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti
- EUDAMED SRN
- TR-MF-000026388
Sources (1)
- EUDAMED 62a4595c-f3d3-41da-819c-c35a6ad6b7bf 61 fields · synced Jun 19, 2026