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Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)
EUDAMEDClass A (EU MDR)
Ref S1001E-48AModel S1001ERef S1001E-24Ref S1001E-48B
Identity
- Trade Name
- Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) EUDAMED
- Device Name
- Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) EUDAMED
- Model / Reference
- S1001E EUDAMEDS1001E-48A EUDAMEDS1001E-24 EUDAMEDS1001E-48B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792700796 EUDAMED06955792713017 EUDAMED06955792700802 EUDAMED
- Basic UDI-DI
- 69557927S1001E000001HP 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 (RNA) Extraction 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 | 69557927S1001E000001HP | 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 af8cd23e-ee30-44ab-a5d5-153e682302f3 61 fields · synced Jul 27, 2026
- EUDAMED 2c6ccc9e-7edb-4386-9c6f-f7d61e4eff1b 61 fields · synced May 17, 2026
- EUDAMED 55121009-8e3c-465c-a8fa-cb4ed81bd03d 61 fields · synced May 18, 2026