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Strongstep® Nucleic acid extraction kit(magnetic beads method)
EUDAMEDClass IVD General (EU MDR)
Ref 504005Model 100 Tests/box
Identity
- Trade Name
- Strongstep® Nucleic acid extraction kit(magnetic beads method) EUDAMED
- Device Name
- Nucleic acid extraction kit(magnetic beads method) EUDAMED
- Model / Reference
- 100 Tests/box EUDAMED504005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181850525 EUDAMED
- Basic UDI-DI
- B-06973181850525 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland 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
Category: Nucleic acid extraction/isolation kit IVD
Strongstep® Nucleic acid extraction kit(magnetic beads method) by Nanjing Liming Bio-products Co. Ltd — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Manufacturer's product page: Nucleic acid extraction kit(magnetic beads method)
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-06973181850525 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Liming Bio-products Co. Ltd
- EUDAMED SRN
- CN-MF-000041298
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 1dee6129-20e4-418b-a810-ccb2ace32519 61 fields · synced Jun 20, 2026