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Hyacyst
EUDAMEDClass IIa (EU MDR)
Ref HYC-4050SModel HYACYST Sterile Sodium Hyaluranate Solution, 40mg
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HYACYST EUDAMED
- Device Name
- HYACYST Sterile Sodium Hyaluranate Solution, 40mg EUDAMED
- Model / Reference
- HYACYST Sterile Sodium Hyaluranate Solution, 40mg EUDAMEDHYC-4050S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698703339491 EUDAMED
- Basic UDI-DI
- B-08698703339491 EUDAMED
- EMDN Code
- U1301 SOLUTIONS FOR BLADDER WASHING AND INSTILLATION EUDAMED
Classification
- Device Class
- Class IIa 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
Hyacyst by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class IIa — 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-08698703339491 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 512aaad4-b612-46cc-b2d2-05971c3500c8 61 fields · synced Jun 14, 2026