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Hyalganbio
EUDAMEDClass III (EU MDR)
Ref 10000120Model EQ0302_1BRef 10000894Model EQ0302_1ARef 10000119
Identity
- Trade Name
- HYALGANBIO EUDAMED
- Device Name
- HYALGANBIO EUDAMED
- Model / Reference
- EQ0302_1B EUDAMED10000120 EUDAMEDEQ0302_1A EUDAMED10000894 EUDAMED10000119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100001202C EUDAMEDD-100008944C EUDAMEDD-100001192T EUDAMED
- Basic UDI-DI
- B-100001202C EUDAMEDB-100008944C EUDAMEDB-100001192T EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMEDCroatia 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
Hyalganbio 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-100001202C | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (3)
- EUDAMED 232a0334-900c-40aa-8626-d4dbfdab2bd5 61 fields · synced Jul 20, 2026
- EUDAMED 16a71a69-4cd9-4fe2-9b68-9b5a07616c55 61 fields · synced Jul 10, 2026
- EUDAMED d855fd50-bb90-44e6-a8b0-472e542c9a22 61 fields · synced Jul 20, 2026