Identity
- Trade Name
- SpO2 Sensor EUDAMED
- Device Name
- Spo2 sensor EUDAMED
- Model / Reference
- AMD-RS-NU8201-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931377212410 EUDAMED
- Basic UDI-DI
- B-06931377212410 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
SpO2 Sensor by Shenzhen Amydi-med Electrics Tech Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06931377212410 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Amydi-med Electrics Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000013201
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 257a2b2e-945a-4351-9b4b-3393b8e76d9a 61 fields · synced Jun 18, 2026