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Fingertip Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref 6100Model SONOSAT-F02LWModel SONOSAT-F02LPModel SONOSAT-F01WModel SONOSAT-F01PModel SONOSAT-F01LWModel SONOSAT-F02LTModel SONOSAT-F02P
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- SONOSAT-F02LW EUDAMED6100 EUDAMEDSONOSAT-F02LP EUDAMEDSONOSAT-F01W EUDAMEDSONOSAT-F01P EUDAMEDSONOSAT-F01LW EUDAMEDSONOSAT-F02LT EUDAMEDSONOSAT-F02P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822531272 EUDAMED06934822531289 EUDAMED06934822531180 EUDAMED06934822531197 EUDAMED06934822531210 EUDAMED06934822531265 EUDAMED06934822531258 EUDAMED
- Basic UDI-DI
- B-06934822531272 EUDAMEDB-06934822531289 EUDAMEDB-06934822531180 EUDAMEDB-06934822531197 EUDAMEDB-06934822531210 EUDAMEDB-06934822531265 EUDAMEDB-06934822531258 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
Fingertip Pulse Oximeter by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06934822531272 | 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 (7)
- EUDAMED edaae56b-caf0-49a1-b151-33b8b01c3961 61 fields · synced Oct 6, 2026
- EUDAMED 20c4035a-d572-4d2d-92d7-9bc7fd33e4f4 61 fields · synced May 17, 2026
- EUDAMED 3f81455a-2889-42fd-9def-35831666d0e0 61 fields · synced May 17, 2026
- EUDAMED 94c816ef-c20d-49f0-81b5-d503fdfae65e 61 fields · synced May 18, 2026
- EUDAMED e9a5c9c9-6e35-4af9-8eb8-b16ce829c914 61 fields · synced May 19, 2026
- EUDAMED 68469945-59ee-487e-bafa-3295b7eb5a93 61 fields · synced May 19, 2026
- EUDAMED 1945752c-1f0c-4adf-a532-be9b0cc57333 61 fields · synced May 19, 2026