Identity
- Trade Name
- StiCol volume EUDAMED
- Device Name
- Sterile Absorbable Poly-L-Lactic acid (PLLA) Dermal Filler EUDAMED
- Model / Reference
- StiCol volume EUDAMEDNot applicable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800125100270 EUDAMED
- Basic UDI-DI
- B-08800125100270 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES 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
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
StiCol volume 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-08800125100270 | 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 4b2faa26-3afb-4f8b-80a5-f1e0c21726a1 61 fields · synced Oct 7, 2026