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DIVES MED Royal Stimulate
EUDAMEDClass III (EU MDR)
Ref Not applicableModel DIVES MED Royal Stimulate
Identity
- Trade Name
- DIVES MED Royal Stimulate EUDAMED
- Device Name
- Sterile Absorbable Poly-L-Lactic acid (PLLA) Dermal Filler EUDAMED
- Model / Reference
- DIVES MED Royal Stimulate EUDAMEDNot applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800125100355 EUDAMED
- Basic UDI-DI
- B-08800125100355 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
DIVES MED Royal Stimulate 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-08800125100355 | 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 66d17ac6-4c2f-44d1-8633-5601c9aa2f4e 61 fields · synced Oct 6, 2026