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Sciendox ® Nucleic acid conversion and purification reagent
EUDAMEDClass A (EU MDR)
Ref 4357101
Identity
- Trade Name
- Sciendox ® Nucleic acid conversion and purification reagent EUDAMED
- Device Name
- Nucleic acid conversion and purification reagent EUDAMED
- Model / Reference
- 4357101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971124110491 EUDAMED
- Basic UDI-DI
- 6971124114357101E3 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
- Germany 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
Sciendox ® Nucleic acid conversion and purification reagent by Xiamen Sciendox Biological Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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
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- 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 | 6971124114357101E3 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Sciendox Biological Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029485
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 62395f10-9987-490c-9586-9304e0210a61 61 fields · synced Jun 17, 2026