Identity
- Trade Name
- Proluma EUDAMED
- Device Name
- Proluma EUDAMED
- Model / Reference
- Proluma EUDAMEDNot applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800125100744 EUDAMED
- Basic UDI-DI
- B-08800125100744 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
Proluma 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-08800125100744 | 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 e5882864-a830-45fd-b5bf-3f2b5887b1b1 61 fields · synced Oct 6, 2026