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Flexgel
EUDAMEDClass III (EU MDR)
Ref FLX-3-60Model FLEXGEL - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%)
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- FLEXGEL EUDAMED
- Device Name
- FLEXGEL - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%) EUDAMED
- Model / Reference
- FLEXGEL - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%) EUDAMEDFLX-3-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699415738114 EUDAMED
- Basic UDI-DI
- B-08699415738114 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
Flexgel 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-08699415738114 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 00b07615-d98c-429c-9a35-3b8b7bf137b9 61 fields · synced Oct 7, 2026