SpO2 Sensor
by Shenzhen Amydi-med Electrics Tech Co., Ltd 5 variants
Ref AMD-RS-AC0062-L
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-06931377208970 06931377208970 | Date23 Mar 2022 | 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- Withdrawn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
- Model / Reference
- AMD-RS-AC0062-L
- Primary DI / UDI-DI
- 06931377208970
- Basic UDI-DI
- B-06931377208970
- EMDN Code
- C900301 Pulse oximeter sensors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000013201
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
From the manufacturer
Manufacturer's product page: SpO2
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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