RD rainbow Lite SET-1 Adt, Adhesive Sensor
Ref 4042
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number084399700000Z1T1B02V103FK 10843997011720 | Date2 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- RD rainbow Lite SET-1
- Model / Reference
- 4042
- Primary DI / UDI-DI
- 10843997011720
- Basic UDI-DI
- 084399700000Z1T1B02V103FK
- Unit of Use DI
- 00843997011723
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000010641
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Masimo Corporation
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