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DNA/RNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref RM302-01Ref RM301-02Ref RM302-02
Identity
- Trade Name
- DNA/RNA Extraction Kit EUDAMED
- Device Name
- DNA/RNA Extraction Kit EUDAMED
- Model / Reference
- RM302-01 EUDAMEDRM301-02 EUDAMEDRM302-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739917 EUDAMED06973315739887 EUDAMED06973315739924 EUDAMED
- Basic UDI-DI
- 6973315739870BU EUDAMED
- Direct Marketing DI
- 06973315739917 EUDAMED06973315739887 EUDAMED06973315739924 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
DNA/RNA Extraction Kit by Nanjing Vazyme Medical Technology 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
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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 | 6973315739870BU | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED f6693250-89e3-4b24-b8ef-fdc17dba535e 61 fields · synced Jul 14, 2026
- EUDAMED 9b15edb3-dbef-404b-b55f-d298103a46c7 61 fields · synced May 18, 2026
- EUDAMED 91f482ef-a419-41c1-b1bb-6bf2f8ce0b24 61 fields · synced May 18, 2026