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Sepsis pathogenic microorganism detection kit (digital PCR)
EUDAMEDClass IVD General (EU MDR)
Ref 3.02.03.0007
Identity
- Trade Name
- Sepsis pathogenic microorganism detection kit (digital PCR) EUDAMED
- Device Name
- Sepsis pathogenic microorganism detection kit (digital PCR) EUDAMED
- Model / Reference
- 3.02.03.0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470148 EUDAMED
- Basic UDI-DI
- B-06975760470148 EUDAMED
- EMDN Code
- W0104080601 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Sepsis pathogenic microorganism detection kit (digital PCR) by Suzhou Precigenome Ltd, Co; — Class IVD General — IVDD — listed in EUDAMED
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-06975760470148 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b132e709-5d24-42b1-b7ed-8aeeb522a86e 61 fields · synced Jul 17, 2026