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Optilube Active
EUDAMEDClass III (EU MDR)
Ref 1168SModel OPTILUBE ACTIVE - Sterile Lubricant Gel With Lidocaine (CHG Free), 11mL Prefilled Syringe (Soft Pouch), 10pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- OPTILUBE ACTIVE EUDAMED
- Device Name
- OPTILUBE ACTIVE - Sterile Lubricant Gel With Lidocaine (CHG Free), 11mL Prefilled Syringe (Soft Pouch) EUDAMED
- Model / Reference
- OPTILUBE ACTIVE - Sterile Lubricant Gel With Lidocaine (CHG Free), 11mL Prefilled Syringe (Soft Pouch), 10pcs/box EUDAMED1168S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060222479171 EUDAMED
- Basic UDI-DI
- B-05060222479171 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
Optilube Active 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-05060222479171 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED e5eee891-e6d7-422a-aaa1-adeba8957515 61 fields · synced Oct 7, 2026