HyaFilia
by CHA Meditech Co., Ltd. 13 variants
Ref HyaFilia M 5.0/F005
Active
CE MDR
Valid until
7 Jan 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000520CFN019Z 08800052003118 | Date30 Mar 2026 | StatusActive |
Certificates
- 2026-AXVI/QS-001 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 7 Jan 2026
- Expires
- 7 Jan 2031
- 2026-AXVI/TD-001 Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 7 Jan 2026
- Expires
- 7 Jan 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dermal Filler (Hyaluronic Acid Filler)
- Model / Reference
- HyaFilia M 5.0/F005
- Primary DI / UDI-DI
- 08800052003118
- Basic UDI-DI
- 88000520CFN019Z
- Direct Marketing DI
- 08800052003118
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- KR-MF-000008782
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from CHA Meditech 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