Model 3231 USB OEM External Pulse Oximeter
Ref 9134-002Model Model 3231 USB
Active
CE MDD
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/MDD | NumberB-00849686085846 00849686085846 | Date20 Nov 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- OEM External Pulse Oximeter
- Model / Reference
- Model 3231 USB, 9134-002
- Primary DI / UDI-DI
- 00849686085846
- Basic UDI-DI
- B-00849686085846
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008228
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
Other devices from Nonin Medical, Inc.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No