SunTech SpO2 Module
Ref 91-0145-00Model WK100
SunTech SpO2 Module (91-0145-00) is a Class IIa device made by SunTech Medical, Inc, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 0840935198026000CN), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0840935198026000CN 10840935111542 | Date30 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 0840935198026000CN
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- SunTech SpO2 Module
- Model / reference
- WK100, 91-0145-00
- Primary DI / UDI-DI
- 10840935111542
- Basic UDI-DI
- 0840935198026000CN
- EMDN code
- Z1203020408 Pulse oximeters
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000002189
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116