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Hyamax®
EUDAMEDClass III (EU MDR)
Ref 2*1mlModel Hyamax® Plus Extra Deep,1.0mlModel Hyamax® Plus Lips,1.0mlModel Hyamax® Plus Fine,1.0mlModel Hyamax® Plus Deep,1.0ml
Identity
- Trade Name
- Hyamax® EUDAMED
- Device Name
- Hyaluronan Soft Tissue Filling Gel EUDAMED
- Model / Reference
- Hyamax® Plus Extra Deep,1.0ml EUDAMED2*1ml EUDAMEDHyamax® Plus Lips,1.0ml EUDAMEDHyamax® Plus Fine,1.0ml EUDAMEDHyamax® Plus Deep,1.0ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649994144029 EUDAMED07649994144036 EUDAMED07649994144043 EUDAMED07649994144012 EUDAMED
- Basic UDI-DI
- B-07649994144029 EUDAMEDB-07649994144036 EUDAMEDB-07649994144043 EUDAMEDB-07649994144012 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Northern Ireland 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
Hyamax® by Laboratories Hyamed SA — 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-07649994144029 | Class III | Active |
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Manufacturer
- Manufacturer
- Laboratories Hyamed SA
- EUDAMED SRN
- CH-MF-000039052
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (4)
- EUDAMED 28741dcf-42c1-4c97-bca7-6a358848171d 61 fields · synced Jul 30, 2026
- EUDAMED c06e8a22-8321-44d0-9a06-bc05986a83b2 61 fields · synced May 17, 2026
- EUDAMED daea9b59-9d40-4fed-96e1-2e2cf4b3fad5 61 fields · synced May 19, 2026
- EUDAMED 364d98b7-2e10-44d9-8ec4-1be91dae7a4b 61 fields · synced May 19, 2026