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Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)
EUDAMEDClass A (EU MDR)
Ref S10012E-48BModel S10012ERef S10012E-96Ref S10012E-48
Identity
- Trade Name
- Nucleic acid extraction (DNA) or purification kit(Magnetic beads method) EUDAMED
- Device Name
- Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) EUDAMED
- Model / Reference
- S10012E EUDAMEDS10012E-48B EUDAMEDS10012E-96 EUDAMEDS10012E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714854 EUDAMED06955792713178 EUDAMED06955792713161 EUDAMED
- Basic UDI-DI
- 69557927S10012E00001G9 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 EUDAMEDItaly 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) 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 | 69557927S10012E00001G9 | 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 193f3f15-409f-42e0-986f-1df1ac876d08 61 fields · synced Aug 2, 2026
- EUDAMED 0c1301bf-9b4d-468a-a9ae-277103db70f1 61 fields · synced May 17, 2026
- EUDAMED d8031944-c551-4ae3-b505-3ad705c92c94 61 fields · synced May 19, 2026