Identity
- Trade Name
- Aquashine PTx EUDAMED
- Device Name
- Soft Filler EUDAMED
- Model / Reference
- Aquashine PTx EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809171381275 EUDAMED08809171381329 EUDAMED
- Basic UDI-DI
- B-08809171381275 EUDAMEDB-08809171381329 EUDAMED
- EMDN Code
- Y062703 AESTHETIC FILLERS, CALF AND THIGH EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMEDDenmark 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
Aquashine PTx by Caregen 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-08809171381275 | Class III | Active |
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Manufacturer
- Manufacturer
- Caregen Co., Ltd.
- EUDAMED SRN
- KR-MF-000009948
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 31d048ad-cc56-445f-9451-7fe56deb55ff 61 fields · synced Jul 9, 2026
- EUDAMED 0e3db833-61ad-4e34-bc70-9591cf728980 61 fields · synced May 17, 2026