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Konsung
EUDAMEDClass IVD General (EU MDR)
Ref 5660SModel DiaCard-1
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Trade Name
- Konsung EUDAMED
- Device Name
- Blood Lipid and Glucose Test Card (Dry Chemical Method) EUDAMED
- Model / Reference
- DiaCard-1 EUDAMED5660S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535058 EUDAMED
- Basic UDI-DI
- B-06934822535058 EUDAMED
- EMDN Code
- W0101060499 MULTIPLE PARAMETERS POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Accurate and reliable blood lipid and glucose testing in a convenient, disposable form. The Konsung device provides fast and easy-to-use results for patients with diabetes or those monitoring their condition closely.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06934822535058 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6304cf9c-9f04-412c-98a7-d70d05f3e855 61 fields · synced Oct 6, 2026