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Nucleic acid Extraction and Purification Kit
EUDAMEDClass A (EU MDR)
Ref -Model Nucleic acid Extraction and Purification Kit
Identity
- Trade Name
- Nucleic acid Extraction and Purification Kit EUDAMED
- Device Name
- RS-HSCF01、RS-HSFF01、RS-HSFF02、RS-HSFF03 EUDAMED
- Model / Reference
- Nucleic acid Extraction and Purification Kit EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141982291 EUDAMED06975141982307 EUDAMED
- Basic UDI-DI
- 697514198RS002LH 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Nucleic acid Extraction and Purification Kit by Hangzhou Allsheng Instruments Co., Ltd — 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
- 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 | 697514198RS002LH | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 7528fdad-e74e-45a8-be64-d5181c9450af 61 fields · synced Aug 2, 2026
- EUDAMED ebc04991-12e6-4498-96df-d61b0c59d53f 61 fields · synced May 17, 2026