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MONALISA Filler
EUDAMEDClass III (EU MDR)
Ref HAF10H27TRef HAF10M27TRef HAF10S27T
Identity
- Trade Name
- MONALISA Filler EUDAMED
- Device Name
- MONALISA Filler EUDAMED
- Model / Reference
- HAF10H27T EUDAMEDHAF10M27T EUDAMEDHAF10S27T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809324765464 EUDAMED08809324765457 EUDAMED08809324765440 EUDAMED
- Basic UDI-DI
- B-08809324765464 EUDAMEDB-08809324765457 EUDAMEDB-08809324765440 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
MONALISA Filler by GENOSS CO., Ltd. — 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-08809324765464 | Class III | Active |
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Manufacturer
- Manufacturer
- GENOSS Co., Ltd.
- EUDAMED SRN
- KR-MF-000029064
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 1e05357e-d8fe-4797-beac-e61f9c584a75 61 fields · synced Jul 17, 2026
- EUDAMED d040ca35-f1bd-448a-9483-e14307bf42f5 61 fields · synced May 18, 2026
- EUDAMED 0f09becd-1f2a-4208-b88e-c52224425b35 61 fields · synced May 19, 2026