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Hyamax®

EUDAMED

Class 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

by Laboratories Hyamed SA

Identity

Trade Name
Hyamax® EUDAMED
Device Name
Hyaluronan Soft Tissue Filling Gel EUDAMED
Model / Reference
Hyamax® Plus Extra Deep,1.0ml EUDAMED
2*1ml EUDAMED
Hyamax® Plus Lips,1.0ml EUDAMED
Hyamax® Plus Fine,1.0ml EUDAMED
Hyamax® Plus Deep,1.0ml EUDAMED

Identifiers

Primary DI / UDI-DI
07649994144029 EUDAMED
07649994144036 EUDAMED
07649994144043 EUDAMED
07649994144012 EUDAMED
Basic UDI-DI
B-07649994144029 EUDAMED
B-07649994144036 EUDAMED
B-07649994144043 EUDAMED
B-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

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Manufacturer

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