SAM® Splint
by SAM Medical Products 5 variants
Ref SP502-OB-DE
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 | Number0822045SP01US 00822045000988 | Date25 Jul 2022 | 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- Withdrawn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
- SP502-OB-DE
- Primary DI / UDI-DI
- 00822045000988
- Basic UDI-DI
- 0822045SP01US
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002589
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from SAM Medical Products
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