Identity
- Trade Name
- Mitelier EUDAMED
- Device Name
- Mitelier EUDAMED
- Model / Reference
- Mitelier EUDAMEDNot applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800125100782 EUDAMED
- Basic UDI-DI
- B-08800125100782 EUDAMED
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mitelier by PRP Science 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-08800125100782 | Class III | Active |
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Manufacturer
- Manufacturer
- PRP Science Co., Ltd.
- EUDAMED SRN
- KR-MF-000014450
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 9fb0c6db-92b1-48fd-a55b-3d784ded295c 61 fields · synced Jun 19, 2026