Identity
- Trade Name
- HYMOVIS ONE EUDAMED
- Device Name
- HYMOVIS ONE EUDAMED
- Model / Reference
- EQE8-02-1B EUDAMED11000342 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-110003423H EUDAMED
- Basic UDI-DI
- B-110003423H EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Hymovis One 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-110003423H | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED 17b48ece-e8e2-44dd-ab6f-8e0d163da68d 61 fields · synced Jun 19, 2026