1CA
by Koru Pharma Co., Ltd EUDAMED
Active
Ref 1CAModel AVALON
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88002066HAFV3 | Date3 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- MDR.2292-2025/0030 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 18 Sep 2026
- Expires
- 9 Dec 2030
- Reason
- Add device or group
Specification
- Model / Reference
- AVALON, 1CA
- Primary DI / UDI-DI
- 08800206600200
- Basic UDI-DI
- 88002066HAFV3
- EMDN Code
- X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
- Device Class
- Class III
- Market of Registration
- Croatia
Manufacturer details
- EUDAMED SRN
- KR-MF-000037958
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Koru Pharma 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