Identity
- Trade Name
- Ureteral Dilator EUDAMED
- Device Name
- Ureteral Dilator EUDAMED
- Model / Reference
- Ureteral Dilator EUDAMEDGUDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683255239320 EUDAMED
- Basic UDI-DI
- 869915834GUDSW2 EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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: Ureteral introduction sheath
Ureteral Dilator 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 Ureteral introduction sheath.
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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 | 869915834GUDSW2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti
- EUDAMED SRN
- TR-MF-000026388
Sources (1)
- EUDAMED f97b52f8-25c6-4bbf-ae8f-4510985bfe28 61 fields · synced Jun 19, 2026