Identity
- Trade Name
- HYALO4 CONTROL EUDAMED
- Device Name
- HYALO4 CONTROL EUDAMED
- Model / Reference
- AQ1408_1B EUDAMED10000061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100000612M EUDAMED
- Basic UDI-DI
- B-100000612M EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Hyalo4 Control by Fidia Farmaceutici S.p.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-100000612M | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED f732d6da-dc92-429e-9dda-81dfb0ee22fb 61 fields · synced Jun 19, 2026