Identity
- Trade Name
- HYACLON ONE EUDAMED
- Device Name
- Intra-Articular Viscosupplementation Device EUDAMED
- Model / Reference
- HUMIA EUDAMEDHYACLON ONE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809162253802 EUDAMED
- Basic UDI-DI
- B-08809162253802 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Hyaclon One by Humedix — 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-08809162253802 | Class III | Active |
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Manufacturer
- Manufacturer
- Humedix
- EUDAMED SRN
- KR-MF-000030230
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 0d2a8a0e-6e7b-4156-b52f-095d5701a68b 61 fields · synced Aug 2, 2026