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Hyalone
EUDAMEDClass III (EU MDR)
Ref 13001235Model EQD2-02-1BRef 10000796Ref 10001093
Identity
- Trade Name
- HYALONE EUDAMED
- Device Name
- HYALONE EUDAMED
- Model / Reference
- EQD2-02-1B EUDAMED13001235 EUDAMED10000796 EUDAMED10001093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-130012354Q EUDAMEDD-100007964B EUDAMEDD-1000109339 EUDAMED
- Basic UDI-DI
- B-130012354Q EUDAMEDB-100007964B EUDAMEDB-1000109339 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMEDAustria EUDAMEDFrance 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
No
EUDAMED
Hyalone by Fidia Farmaceutici S.p.A. — 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-130012354Q | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (3)
- EUDAMED 71d3766e-a7dc-4819-a73f-383c5ef2906a 61 fields · synced Jul 29, 2026
- EUDAMED a805d2f7-b856-4569-947b-13dcb1685c7b 61 fields · synced May 18, 2026
- EUDAMED 80f69329-8c4c-4c4a-9964-b41f1ffd5ae1 61 fields · synced May 19, 2026