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Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method)
EUDAMEDClass A (EU MDR)
Ref S10013E-48 Model S10013E
Identity
- Trade Name
- Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) EUDAMED
- Device Name
- Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) EUDAMED
- Model / Reference
- S10013E EUDAMEDS10013E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792713192 EUDAMED
- Basic UDI-DI
- 69557927S10013E00001GS 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
Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED
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 (1)
- EUDAMED f5d790d2-2d49-4681-82ff-2ffaa5deeeee 61 fields · synced Jun 17, 2026