Duk-In N-Splint
by Duk-In Co., Ltd. EUDAMED
Active
Ref S4210Model Splint
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000337SP200FL | Date16 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Synthetic Orthopedic Splint
- Model / Reference
- Splint, S4210
- Primary DI / UDI-DI
- 08800033701453, 08800033701446
- Basic UDI-DI
- 88000337SP200FL, 88000337SPLINT200K8
- Direct Marketing DI
- 0880003370145308800033701446
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- KR-MF-000026961
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Duk-In Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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