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Wrist Pulse Oximeter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6200Model SONOSAT-W01LWModel SONOSAT-W01PModel SONOSAT-W01W
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Wrist Pulse Oximeter EUDAMED
- Model / Reference
- SONOSAT-W01LW EUDAMED6200 EUDAMEDSONOSAT-W01P EUDAMEDSONOSAT-W01W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822531333 EUDAMED06934822531319 EUDAMED06934822531302 EUDAMED
- Basic UDI-DI
- B-06934822531333 EUDAMEDB-06934822531319 EUDAMEDB-06934822531302 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wrist Pulse Oximeter by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152089 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06934822531333 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 23f4acaf-30f2-4dc7-bb5c-27aed9f00a85 61 fields · synced Oct 6, 2026
- EUDAMED 00fd94f8-bbcf-48a8-a3c4-c62a072a0392 61 fields · synced May 19, 2026
- EUDAMED b2ba10c9-cade-4d84-b19a-508d7d84a8fd 61 fields · synced May 19, 2026
- FDA 510(k) K152089 1 fields · synced May 18, 2026