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Nucleic Acid Extraction-Purification Kit IV-IX
EUDAMEDClass A (EU MDR)
Ref S4009E-48Ref S4009E-48BRef S4009E-32-S
Identity
- Device Name
- Nucleic Acid Extraction-Purification Kit IV-IX EUDAMED
- Model / Reference
- S4009E-48 EUDAMEDS4009E-48B EUDAMEDS4009E-32-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792701588 EUDAMED06955792701601 EUDAMED06955792701618 EUDAMED
- Basic UDI-DI
- 69557927S4009E000001RC 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
Yes
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Acid Extraction-Purification Kit IV-IX by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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
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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
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 | 69557927S4009E000001RC | 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 6ee9c647-7bf5-43e8-9de6-0ac0f7a8ca32 61 fields · synced Jul 19, 2026
- EUDAMED a1de2849-5194-4655-a994-8194bc091f96 61 fields · synced May 18, 2026
- EUDAMED 20a1f01b-16a2-4d6e-b3fa-0e070ec0aab1 61 fields · synced May 18, 2026