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Hyalo4 Care Start
EUDAMEDClass III (EU MDR)
Ref 10001064Model HQC6-05-1ARef 13001296Model AQA9-09-1DRef 13001294
Identity
- Trade Name
- HYALO4 CARE START EUDAMEDHYALO4 CARE EUDAMED
- Device Name
- HYALO4 CARE START EUDAMEDHYALO4 CARE EUDAMED
- Model / Reference
- HQC6-05-1A EUDAMED10001064 EUDAMEDAQA9-09-1D EUDAMED13001296 EUDAMED13001294 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1000106432 EUDAMEDD-130012965C EUDAMEDD-1300129458 EUDAMED
- Basic UDI-DI
- B-1000106432 EUDAMEDB-130012965C EUDAMEDB-1300129458 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMEDM9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass IIb EUDAMED
- Market of Registration
- France 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
EUDAMEDEUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Hyalo4 Care Start by Fidia Farmaceutici S.p.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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-1000106432 | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (3)
- EUDAMED 472c6221-8aef-4fa2-9225-820e7e4792f3 61 fields · synced Jul 18, 2026
- EUDAMED 4bacb4d5-8a2b-48a4-aeb2-44c2e19b5274 61 fields · synced Jul 9, 2026
- EUDAMED 4cb73d89-5845-4dbd-86e2-473462354d78 61 fields · synced Jul 18, 2026