Identity
- Trade Name
- Hyalmass (Hard) EUDAMED
- Device Name
- Hyalmass (Hard) EUDAMED
- Model / Reference
- MPF10H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026543336 EUDAMED
- Basic UDI-DI
- B-08800026543336 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Hyalmass (Hard) 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-08800026543336 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GENOSS Co., Ltd.
- EUDAMED SRN
- KR-MF-000029064
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d6d759f9-bcce-4a35-a6d1-a8defb1c722c 61 fields · synced Jun 18, 2026