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Hyalotend
EUDAMEDClass III (EU MDR)
Ref 10000503Model EQP201_1ARef 11000356Ref 10000123Model EQP201_1BRef 10000257Ref 11000357
Identity
- Trade Name
- HYALOTEND EUDAMED
- Device Name
- HYALOTEND EUDAMED
- Model / Reference
- EQP201_1A EUDAMED10000503 EUDAMED11000356 EUDAMEDEQP201_1B EUDAMED10000123 EUDAMED10000257 EUDAMED11000357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100005032Y EUDAMEDD-110003563U EUDAMEDD-100001232J EUDAMEDD-1000025738 EUDAMEDD-110003573W EUDAMED
- Basic UDI-DI
- B-100005032Y EUDAMEDB-110003563U EUDAMEDB-100001232J EUDAMEDB-1000025738 EUDAMEDB-110003573W EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMEDRomania EUDAMEDItaly EUDAMEDGermany EUDAMEDAustria 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
Hyalotend 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-100005032Y | Class III | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (5)
- EUDAMED e54f67a5-9c49-4b46-931b-0c699a3056db 61 fields · synced Jul 23, 2026
- EUDAMED ca63b53b-0b04-4da9-be30-8e740b0a8c9b 61 fields · synced May 16, 2026
- EUDAMED 268805c9-c4f4-4563-a123-f0125f26bc0d 61 fields · synced May 17, 2026
- EUDAMED 5d725c4c-fccc-4366-8700-bacae0676184 61 fields · synced May 19, 2026
- EUDAMED 66e71460-c67d-4d8c-925b-039741bbe5a8 61 fields · synced Jul 23, 2026