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konsung
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SONOSAT-F01TRef 6120Model SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LPRef 5660SModel DiaCard-1Ref 5600SModel DiaCard-2Model DiaCard-3
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Trade Name
- konsung EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Fingertip Pulse Oximeter EUDAMEDBlood Lipid and Glucose Test Card (Dry Chemical Method) EUDAMEDThis device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. power supply is 3.7V Li-battery and also the subject device can be powered by adapter. The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer. FDA UDI
- Model / Reference
- SONOSAT-F01T EUDAMEDFDA UDISONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP EUDAMED6120 EUDAMEDDiaCard-1 EUDAMED5660S EUDAMEDDiaCard-2 EUDAMED5600S EUDAMEDDiaCard-3 EUDAMED
- Description
- This device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. power supply is 3.7V Li-battery and also the subject device can be powered by adapter. The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934822531173 EUDAMEDFDA UDI06934822531081 EUDAMED06934822535041 EUDAMED06934822535089 EUDAMED06934822531043 EUDAMED06934822535096 EUDAMED06934822531050 EUDAMED06934822531166 EUDAMED06934822531098 EUDAMED06934822535034 EUDAMED06934822535065 EUDAMED06934822531128 EUDAMED06934822531012 EUDAMED06934822531135 EUDAMED06934822531036 EUDAMED06934822531029 EUDAMED
- Basic UDI-DI
- B-06934822531173 EUDAMED693482256120HL EUDAMEDB-06934822535041 EUDAMEDB-06934822535089 EUDAMEDB-06934822535096 EUDAMEDB-06934822535034 EUDAMEDB-06934822535065 EUDAMED
- 510(k) Number
- K152091 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMEDZ1203020408 PULSE OXIMETERS EUDAMEDW0101060499 MULTIPLE PARAMETERS POC - OTHER EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDBelgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
konsung by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IIa — MDR, MDD, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06934822531173 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06934822531173 | Class IIa | Active |
| EUDAMED | European Union | CE/IVDD | B-06934822531173 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (17)
- EUDAMED 0b5cd957-8155-4a8f-ab58-cc78fdbef6d4 61 fields · synced Oct 7, 2026
- EUDAMED 26f0620a-2cb0-492d-abf2-93da3d7c2c25 61 fields · synced May 16, 2026
- EUDAMED 2260530f-d996-4975-908c-d6e3efb5ec1a 61 fields · synced May 16, 2026
- EUDAMED e565d6b3-e903-482f-886e-0c4634d1d7e3 61 fields · synced May 17, 2026
- EUDAMED 96d8a749-af52-4b2c-9766-ad5e6c4f27b8 61 fields · synced May 17, 2026
- EUDAMED e714070c-028a-4c8e-8e22-154bfb1b32a1 61 fields · synced May 17, 2026
- EUDAMED 89900956-0722-4888-9967-fd33dac7da01 61 fields · synced May 17, 2026
- EUDAMED 53930aa3-5553-4dce-ad6a-9165e5af4976 61 fields · synced May 17, 2026
- EUDAMED 81f8f5b2-23e7-4f9a-aa0b-b61632479628 61 fields · synced May 17, 2026
- EUDAMED e8ee6351-df45-446c-83ff-1ac2745382ab 61 fields · synced May 17, 2026
- EUDAMED b58edfd6-f1a2-4145-a5fe-5b9a70ba5aac 61 fields · synced May 18, 2026
- FDA UDI a1f7ad4d-2555-4bfa-b06b-80924aad4fe2 34 fields · synced May 30, 2026
- EUDAMED 250bef10-3170-4e11-85f6-34dd4fcd7d43 61 fields · synced Jul 9, 2026
- EUDAMED 5592e57a-5e78-460c-a72a-dc74d935b511 61 fields · synced Jul 11, 2026
- EUDAMED 5b59fb53-ddef-4706-864f-efeb85d340c3 61 fields · synced Jul 17, 2026
- EUDAMED 97816fd9-987d-486c-88a4-a91b9c326fb1 61 fields · synced Jul 21, 2026
- EUDAMED 1b38a4ae-3553-4c3e-ac7f-53f693942fee 61 fields · synced Oct 6, 2026