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Lubragel
EUDAMEDClass III (EU MDR)
Ref LG-L 006Model LUBRAGEL - Sterile Lubricant Gel With Lidocaine, 6mL, 25pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- LUBRAGEL EUDAMED
- Device Name
- LUBRAGEL - Sterile Lubricant Gel With Lidocaine, 6mL EUDAMED
- Model / Reference
- LUBRAGEL - Sterile Lubricant Gel With Lidocaine, 6mL, 25pcs/box EUDAMEDLG-L 006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18699415724541 EUDAMED
- Basic UDI-DI
- B-18699415724541 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
Yes
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
Lubragel 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-18699415724541 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 712ba66c-301f-4ef6-9e9e-4588d2e34242 61 fields · synced Oct 6, 2026