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Optilube
EUDAMEDClass IIa (EU MDR)
Ref 1125Model OPTILUBE - Sterile Water Soluble Lubricating Gel, 6mL Prefilled Syringe, 25pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- OPTILUBE EUDAMED
- Device Name
- OPTILUBE - Sterile Water Soluble Lubricating Gel, 6mL Prefilled Syringe EUDAMED
- Model / Reference
- OPTILUBE - Sterile Water Soluble Lubricating Gel, 6mL Prefilled Syringe, 25pcs/box EUDAMED1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060222470710 EUDAMED
- Basic UDI-DI
- B-05060222470710 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optilube by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class IIa — 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-05060222470710 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 783081c0-cb7f-4a9f-b727-5f7bffa34855 61 fields · synced Oct 8, 2026