Reusable SpO2 sensors
by Solaris Medical Technology, Inc United States(FDA 510(k) applicant) EUDAMED
Ref Y100-300103(C)Model Y100 EMDN C900301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06900234101990 | Date22 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- pulse oixmeter sensor ，Reusable
- Model / Reference
- Y100, Y100-300103(C)
- Primary DI / UDI-DI
- 06900234101990
- Basic UDI-DI
- B-06900234101990
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000038492
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Solaris Medical Technology, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 49359a8f-bc9d-4b59-a069-93d1723ea4e4