Identity
- Trade Name
- SUPARTZ EUDAMED
- Device Name
- SUPARTZ EUDAMED
- Model / Reference
- SUPARTZ EUDAMED30143 EUDAMED30142 EUDAMED30141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987541301437 EUDAMED04987541301420 EUDAMED04987541301413 EUDAMED
- Basic UDI-DI
- B-04987541301437 EUDAMEDB-04987541301420 EUDAMEDB-04987541301413 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Supartz by Seikagaku Corporation — 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-04987541301437 | Class III | Active |
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Manufacturer
- Manufacturer
- Seikagaku Corporation
- EUDAMED SRN
- JP-MF-000008732
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 8a4a473b-eb2c-42e1-ba93-6985afe0c02d 61 fields · synced Jul 27, 2026
- EUDAMED ed5ba623-d85a-45e2-8444-11ca54d986a3 61 fields · synced May 17, 2026
- EUDAMED ba876aa8-10b9-4058-ab5c-d3a96b7112dc 61 fields · synced May 17, 2026