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Automated Blood Culture Analyzer
EUDAMEDClass A (EU MDR)
Ref 100.00kgModel SepCheck
Identity
- Device Name
- Automated Blood Culture Analyzer EUDAMED
- Model / Reference
- SepCheck EUDAMED100.00kg EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897138850050 EUDAMED
- Basic UDI-DI
- 489713885SepCheckV2 EUDAMED
- Direct Marketing DI
- 04897138850050 EUDAMED
- EMDN Code
- W02030201 AUTOMATED BLOOD CULTURE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated Blood Culture Analyzer by Grant Technology (HK) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 489713885SepCheckV2 | Class A | Active |
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Manufacturer
- Manufacturer
- Grant Technology (HK) Co., Ltd.
- EUDAMED SRN
- HK-MF-000041730
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 974b9b4f-72bc-47eb-851e-3a90f57fba30 61 fields · synced Jul 10, 2026