Disposable SpO2 Sensor
by Shenzhen Amydi-med Electrics Tech Co., Ltd 8 variants
Ref AMD-DS-PM0001-1, AMD-DS-AT0001-1, AMD-DS-PF0001-1, AMD-DS-NM0020-2, AMD-DS-AS0020-1, AMD-DS-AM0001-1, AMD-DS-PS0002-1, AMD-DS-IM0001-1, AMD-DS-NF0001-1, AMD-RS-PT6501-S, AMD-DS-AS0001-1, AMD-RS-AE6501-S, AMD-DS-PT0001-1, AMD-DS-NM0028-1, AMD-DS-NM0012-1
Disposable SpO2 Sensor (AMD-DS-PM0001-1) is a device classified as Class IIb and Class IIa in the EU made by Shenzhen Amydi-med Electrics Tech Co., Ltd, registered in EUDAMED on 28 Feb 2022 (Basic UDI-DI B-06931377213356), active as of 22 Oct 2026.
Active
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/MDD | NumberB-06931377213356 | Date28 Feb 2022 | StatusActive |
Official records
- EUDAMED public site B-06931377213356
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade name
- Disposable SpO2 SensorSpO2 Sensor
- Model / reference
- AMD-DS-PM0001-1, AMD-DS-AT0001-1, AMD-DS-PF0001-1, AMD-DS-NM0020-2, AMD-DS-AS0020-1, AMD-DS-AM0001-1, AMD-DS-PS0002-1, AMD-DS-IM0001-1, AMD-DS-NF0001-1, AMD-RS-PT6501-S, AMD-DS-AS0001-1, AMD-RS-AE6501-S, AMD-DS-PT0001-1, AMD-DS-NM0028-1, AMD-DS-NM0012-1
- Primary DI / UDI-DI
- 06931377213356, 06931377202879, 06931377202886, 06931377214230, 06931377214124, 06931377213332, 06931377213448, 06931377202909, 06931377202930, 06931377212373, 06931377200394, 06931377212328, 06931377213370, 06931377201599, 06931377218085
- Basic UDI-DI
- B-06931377213356, B-06931377202879, B-06931377202886, B-06931377214230, B-06931377214124, B-06931377213332, B-06931377213448, B-06931377202909, B-06931377202930, B-06931377212373, B-06931377200394, B-06931377212328, B-06931377213370, B-06931377201599, B-06931377218085
- EMDN code
- C900301, Z1203020285
- Device class
- Class IIbClass IIa
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- TürkiyeGermanyNetherlandsItalyFranceFinlandDenmarkAustria
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: 0.9m White Lemo Disposable Spo2 Sensor Customized 7Pin Sponge
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