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Optiflush
EUDAMEDClass III (EU MDR)
Ref 1133Model Sterile 0,9% Sodium Chloride Solution, 10mL
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- OPTIFLUSH EUDAMED
- Device Name
- Sterile 0,9% Sodium Chloride Solution,10 mL EUDAMED
- Model / Reference
- Sterile 0,9% Sodium Chloride Solution, 10mL EUDAMED1133 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060222471410 EUDAMED
- Basic UDI-DI
- B-05060222471410 EUDAMED
- EMDN Code
- A02010299 INFUSION AND IRRIGATION SYRINGES - 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
Optiflush 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-05060222471410 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 5b441fa1-07f8-4227-820b-a08129e6a17a 61 fields · synced Oct 7, 2026