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U-Gel
EUDAMEDClass III (EU MDR)
Ref UG-G 12,5Model U-GEL - Sterile Lubricant Gel With Lidocaine, 12,5g
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- U-GEL EUDAMED
- Device Name
- U-GEL - Sterile Lubricant Gel With Lidocaine, 12,5g EUDAMED
- Model / Reference
- U-GEL - Sterile Lubricant Gel With Lidocaine, 12,5g EUDAMEDUG-G 12,5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415733970 EUDAMED
- Basic UDI-DI
- B-18699415733970 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
U-Gel by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18699415733970 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (2)
- EUDAMED cfe039ec-99ec-4055-82bd-0ebe2a09dfc9-1 61 fields · synced Oct 7, 2026
- EUDAMED cfe039ec-99ec-4055-82bd-0ebe2a09dfc9-2 61 fields · synced Jul 9, 2026