Okmsystem
by OKM Quimica Ortopedica, S.L. 308 variants
Ref KP09GS
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 | Number8437023092SYS001BQ 08436627662000 | Date10 Jun 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- Withdrawn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
- Device Name
- Nubolo Static
- Model / Reference
- KP09GS
- Primary DI / UDI-DI
- 08436627662000
- Basic UDI-DI
- 8437023092SYS001BQ
- EMDN Code
- M030504 Immobilisation systems, mouldable under cold and hot temperatures
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000005168
Other devices from OKM Quimica Ortopedica, S.L.
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