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U-Gel
EUDAMEDClass III (EU MDR)
Ref UG-G 006Model U-GEL - Sterile Lubricant Gel With Lidocaine, 6mL
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, 6mL EUDAMED
- Model / Reference
- U-GEL - Sterile Lubricant Gel With Lidocaine, 6mL EUDAMEDUG-G 006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415733956 EUDAMED
- Basic UDI-DI
- B-18699415733956 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-18699415733956 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED daabc4bd-04fa-4232-84f2-7d2b940a3e68 61 fields · synced Oct 11, 2026