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Sensoflex
EUDAMEDClass III (EU MDR)
Ref SLX-2-32Model SENSOFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1,6%)
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- SENSOFLEX EUDAMED
- Device Name
- SENSOFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1,6%) EUDAMED
- Model / Reference
- SENSOFLEX - Sterile Sodium Hyaluronate Gel 2mL Prefilled Syringe (1,6%) EUDAMEDSLX-2-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699415734109 EUDAMED
- Basic UDI-DI
- B-08699415734109 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
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
Sensoflex 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-08699415734109 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED b0bf5701-a216-4c01-a9ff-d7a181675d70 61 fields · synced Oct 5, 2026