Dorothy
by CHA Meditech Co., Ltd. EUDAMED
Active
Ref Dorothy 3.0/CMD003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000520CFN019Z | Date30 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-AXVI/QS-001 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Jan 2026
- Expires
- 7 Jan 2031
- 2026-AXVI/TD-001 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Jan 2026
- Expires
- 7 Jan 2031
Specification
- Device Name
- Dermal Filler (Hyaluronic Acid Filler)
- Model / Reference
- Dorothy 3.0/CMD003
- Primary DI / UDI-DI
- 08800052003262
- Basic UDI-DI
- 88000520CFN019Z
- Direct Marketing DI
- 08800052003262
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- 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