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Sinocare
EUDAMEDClass IVD General (EU MDR)
Ref 12600550Ref 5Y002DDModel Safe AQ pro ⅠRef 12600163Ref 12600548Ref 1N002DDModel Safe-AccuRef 12600159Ref 10500022 Model PCH-50Ref 5Y001DDModel Safe AQ pro IRef N/AModel i6, H6, i7, H7Ref 12600539Ref 12600540
Identity
- Trade Name
- Sinocare EUDAMEDSinocare iCan EUDAMED
- Device Name
- Pepsinogen I/Pepsinogen II Reagent Kit EUDAMEDBlood Glucose Test Strip EUDAMEDBlood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C) EUDAMEDHeart-type fatty acid-binding protein Reagent Kit EUDAMEDBlood Glucose Monitoring System EUDAMEDAlanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit EUDAMEDPortable Glycosylated Hemoglobin Analyzer EUDAMEDContinuous Glucose Monitoring System EUDAMEDElectrolyte (K/Na/Cl/Ca) Reagent Kit EUDAMEDLipoprotein-associated Phospholipase A2 Reagent Kit EUDAMEDElectrolyte (CO2/Mg/P/Fe) Reagent Kit EUDAMED
- Model / Reference
- 12600550 EUDAMEDSafe AQ pro Ⅰ EUDAMED5Y002DD EUDAMED12600163 EUDAMED12600548 EUDAMEDSafe-Accu EUDAMED1N002DD EUDAMED12600159 EUDAMEDPCH-50 EUDAMED10500022 EUDAMEDSafe AQ pro I EUDAMED5Y001DD EUDAMEDi6, H6, i7, H7 EUDAMEDN/A EUDAMED12600539 EUDAMED12600540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934175009398 EUDAMED06934175016747 EUDAMED06934175001507 EUDAMED06934175009411 EUDAMED06934175005598 EUDAMED06934175001477 EUDAMED06934175006137 EUDAMED06934175016594 EUDAMED06934175007479 EUDAMED06934175009329 EUDAMED06934175009435 EUDAMED06934175009336 EUDAMED
- Basic UDI-DI
- B-06934175009398 EUDAMEDB-06934175016747 EUDAMEDB-06934175001507 EUDAMEDB-06934175009411 EUDAMEDB-06934175005598 EUDAMEDB-06934175001477 EUDAMED6934175004A0001P8 EUDAMEDB-06934175016594 EUDAMED6934175005A0005PV EUDAMEDB-06934175009329 EUDAMEDB-06934175009435 EUDAMEDB-06934175009336 EUDAMED
- Direct Marketing DI
- 06934175006137 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMEDW01010228 TOTAL LIPIDS EUDAMEDW0102160705 HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC EUDAMEDW0201060102 BLOOD GLUCOSE METERS EUDAMEDW01010103 ALANINE AMINO-TRANSFERASE EUDAMEDW0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMEDW0101060101,W0201060102 EUDAMEDZ1204011502 INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMEDW01010309 SODIUM EUDAMEDW01010302 BICARBONATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD Annex II List B EUDAMEDClass A EUDAMEDClass IIb EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
EUDAMEDEUDAMED
Self Testing
No
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sinocare by Changsha Sinocare Inc. — Class IVD General — MDR, IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06934175009398 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDR | B-06934175009398 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06934175009398 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (13)
- EUDAMED 945f753f-d9f3-4e87-aa02-0d4ff92c6cf0 61 fields · synced Aug 4, 2026
- EUDAMED 94255b01-083f-4ec9-97cc-f1c021e204ad 61 fields · synced May 17, 2026
- EUDAMED a6b5efbc-19d3-4730-be65-96578a56b74b 61 fields · synced May 17, 2026
- EUDAMED 8ae2ada4-8125-4ac6-8066-e6e039d45344 61 fields · synced May 17, 2026
- EUDAMED 95ee6eb2-d90c-4785-bc23-6a4455d7d614 61 fields · synced May 17, 2026
- EUDAMED 815b5ea4-eeec-40c7-a4da-3fe53efb1c06 61 fields · synced May 17, 2026
- EUDAMED f9fb9146-9d86-4fbe-a368-2a3be2ee448e 61 fields · synced May 17, 2026
- EUDAMED 1be3cc4a-1fc9-41a1-9d07-d742ad5fd16b 61 fields · synced May 18, 2026
- EUDAMED 211915a8-b888-49f1-b519-74149dd16959 61 fields · synced May 18, 2026
- EUDAMED 211915a8-b888-49f1-b519-74149dd16959-1 61 fields · synced Jun 10, 2026
- EUDAMED a311d5b0-c7d6-4da9-b189-4fe2ff22fe04 61 fields · synced Jul 12, 2026
- EUDAMED ad776fe1-9bf5-4933-8680-1aa9abe555da 61 fields · synced Jul 23, 2026
- EUDAMED 817aae31-d654-4ed6-8f51-c46bda665aa5 61 fields · synced Aug 4, 2026