SKMD Silicon Rod & Mat
by SungKwang Meditech., Co., Ltd. 14 variants
Ref SK-31-3-aModel SK-31
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 | Number8809240002SiliconSG 08809240020074 | Date27 May 2026 | 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- Withdrawn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
- Model / Reference
- SK-31, SK-31-3-a
- Primary DI / UDI-DI
- 08809240020074
- Basic UDI-DI
- 8809240002SiliconSG
- EMDN Code
- V0880 Medical support equipment - accessories
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000030429
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from SungKwang Meditech., 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