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Lactate dehydrogenase，α-hydroxybutyrate dehydrogenase，creatine kinase，creatine …
EUDAMEDClass IVD General (EU MDR)
Ref 20 pcs/boxModel DiaCard-9
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Lactate dehydrogenase，α-hydroxybutyrate dehydrogenase，creatine kinase，creatine kinase MB test card (dry chemical method) EUDAMED
- Model / Reference
- DiaCard-9 EUDAMED20 pcs/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535454 EUDAMED
- Basic UDI-DI
- B-06934822535454 EUDAMED
- EMDN Code
- W0101060401 MULTIPLE ENZYMES &/OR SUBSTRATES &/OR ELECTROLYTES 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
Lactate dehydrogenase，α-hydroxybutyrate dehydrogenase，creatine kinase，creatine … by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IVD…
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-06934822535454 | 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 e9377848-5a6a-49de-b34d-db14379a3f5c 61 fields · synced Jun 19, 2026