← Back to catalogue
Hyalo4 Plus
EUDAMEDClass III (EU MDR)
Ref 10000097Model AQ1409_1ARef 10000098Model AQ1409_1BRef 10000376
Identity
- Trade Name
- HYALO4 PLUS EUDAMED
- Device Name
- HYALO4 PLUS EUDAMED
- Model / Reference
- AQ1409_1A EUDAMED10000097 EUDAMEDAQ1409_1B EUDAMED10000098 EUDAMED10000376 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100000973A EUDAMEDD-100000983C EUDAMEDD-100003763H EUDAMED
- Basic UDI-DI
- B-100000973A EUDAMEDB-100000983C EUDAMEDB-100003763H EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDCzechia 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 Plus by Fidia Farmaceutici S.p.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
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-100000973A | 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 (3)
- EUDAMED d793d152-00a5-4b64-a6bf-e608b726ae52 61 fields · synced Jul 25, 2026
- EUDAMED 9ce89fc0-56c6-4652-89ca-ce19732a882b 61 fields · synced Jul 10, 2026
- EUDAMED 42955c27-6c0e-45b9-8caa-950b87c14624 61 fields · synced Jul 25, 2026