Cross-Linked HA Soft Tissue Filing Gel
Ref VOLUS 10™
Active
CE MDR
Valid until
17 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880942707ACVLLE 08809427070465 | Date23 Aug 2026 | StatusActive |
Certificates
- 2025-MDR/QS-002/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 17 Aug 2026
- Expires
- 17 Jan 2030
- Reason
- Ar data change
- 2025-MDR/TD-002/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 17 Aug 2026
- Expires
- 17 Jan 2030
- Reason
- Ar data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cross-Linked HA Soft Tissue Filing Gel
- Model / Reference
- VOLUS 10™
- Primary DI / UDI-DI
- 08809427070465
- Basic UDI-DI
- 880942707ACVLLE
- Direct Marketing DI
- 08809427070465
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- KR-MF-000012936
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from Across Co., Ltd.
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No