Duk-In N-Splint
by Duk-In Co., Ltd. 13 variants
Ref S4825Model Splint
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000337SP200FL 08800033701620 | Date16 Jun 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Synthetic Orthopedic Splint
- Model / Reference
- Splint, S4825
- Primary DI / UDI-DI
- 08800033701620
- Basic UDI-DI
- 88000337SP200FL
- Direct Marketing DI
- 08800033701620
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
- EU 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 (13)
- Sterile: No
- Implantable: No
- 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