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Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)
EUDAMEDClass IVD General (EU MDR)
Ref F01003A-96Ref F01003A-24
Identity
- Device Name
- Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification) EUDAMED
- Model / Reference
- F01003A-96 EUDAMEDF01003A-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440723 EUDAMED06975102440747 EUDAMED
- Basic UDI-DI
- B-06975102440723 EUDAMEDB-06975102440747 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification) by Jiangsu Qitian Gene biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-06975102440723 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED f55a58f3-4996-4d9d-b6e7-8776ef9a8d09 61 fields · synced Jul 27, 2026
- EUDAMED bc329a4f-2864-4af4-8ad6-0e58ae7ce6a0 61 fields · synced May 18, 2026