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Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method)
EUDAMEDClass A (EU MDR)
Ref S10013E-24Model S10013ERef S10011E-48Model S10011ERef S10011E-24
Identity
- Trade Name
- Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) EUDAMEDNucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) EUDAMED
- Device Name
- Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) EUDAMEDNucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) EUDAMED
- Model / Reference
- S10013E EUDAMEDS10013E-24 EUDAMEDS10011E EUDAMEDS10011E-48 EUDAMEDS10011E-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792713185 EUDAMED06955792713826 EUDAMED06955792713154 EUDAMED
- Basic UDI-DI
- 69557927S10013E00001GS EUDAMED69557927S10011E00001FQ EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- 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
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 | 69557927S10013E00001GS | Class A | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 282b620f-4c63-4dc4-ae52-b44449e2e13a 61 fields · synced Jul 16, 2026
- EUDAMED d8b61219-ff0b-4236-a398-4e13ff98a332 61 fields · synced May 18, 2026
- EUDAMED c8e87e07-c499-4a5a-ac2f-f6a3cd3dd608 61 fields · synced May 19, 2026