PURILAX Deep
by S.THEPHARM Co., Ltd. EUDAMED
Active
Ref 130213Model QTFILL PLUS AQ, QTFILL PLUS FINE, QTFILL PLUS DEEP, QTFILL PLUS Sub-Q
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000490QTFPRH | Date26 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-AXVI/QS-001/B Supplemented
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 9 Sep 2026
- Expires
- 14 Nov 2030
- Reason
- Other
- 2025-AXVI/TD-001/B Supplemented
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 9 Sep 2026
- Expires
- 14 Nov 2030
- Reason
- Other
Specification
- Device Name
- Cross-linked Hyaluronic Acid injectable gel with Lidocaine / QTFILL PLUS
- Model / Reference
- QTFILL PLUS AQ, QTFILL PLUS FINE, QTFILL PLUS DEEP, QTFILL PLUS Sub-Q, 130213
- Primary DI / UDI-DI
- 08800049001240
- Basic UDI-DI
- 88000490QTFPRH
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000020813
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from S.THEPHARM Co., Ltd.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No