Identity
- Trade Name
- GEN US (Ultra) EUDAMED
- Device Name
- GEN US (Ultra) EUDAMED
- Model / Reference
- MPF10U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026543268 EUDAMED
- Basic UDI-DI
- B-08800026543268 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
GEN US (Ultra) 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-08800026543268 | 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 (1)
- EUDAMED 46e1d64b-cb9f-4224-9479-1d0ee391af92 61 fields · synced Jul 19, 2026