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Rejenart
EUDAMEDClass III (EU MDR)
Ref RA-3-60Model REJENART - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%)
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- REJENART EUDAMED
- Device Name
- REJENART - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%) EUDAMED
- Model / Reference
- REJENART - Sterile Sodium Hyaluronate Gel 3mL Prefilled Syringe (2,0%) EUDAMEDRA-3-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699415734048 EUDAMED
- Basic UDI-DI
- B-08699415734048 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
Rejenart 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-08699415734048 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 11be7183-7196-4e0e-ba1b-c44a1134a864 61 fields · synced Oct 6, 2026