Identity
- Trade Name
- HYAL SYSTEM LIP EUDAMED
- Device Name
- HYAL SYSTEM LIP EUDAMED
- Model / Reference
- QQE3-01-1A1 EUDAMED10001261 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1000126136 EUDAMED
- Basic UDI-DI
- B-1000126136 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Hyal System Lip 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-1000126136 | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED 30b1d088-1d0f-494f-b5fd-db2862712cc4 61 fields · synced Jul 20, 2026