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Beiwo
EUDAMEDClass A (EU MDR)
Ref BW-MGD2311-A32Model BW-MGD2311-A32 BW-MGD2311-A96Ref BW-MR6532-A32Model BW-MR6532-A32 BW-MR6532-A96Ref BW-MGD2411-A00Model BW-MGD2411-A00
BW-MGD2411-A32
BW-MGD2411-A32-32
BW-MGD2411-A96
Ref BW-MGD2318-A32Model BW-MGD2318-A32 BW-MGD2318-A96
Identity
- Trade Name
- BEIWO EUDAMED
- Device Name
- Blood gDNA Isolation Kit (Beads) EUDAMEDExpress MgPure Viral RNA Purification Kit (Beads) EUDAMEDPathogen DNA/RNA Purification Kit (Beads) EUDAMEDSaliva gDNA Isolation Kit (Beads) EUDAMED
- Model / Reference
- BW-MGD2311-A32 BW-MGD2311-A96 EUDAMEDBW-MGD2311-A32 EUDAMEDBW-MR6532-A32 BW-MR6532-A96 EUDAMEDBW-MR6532-A32 EUDAMEDBW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96 EUDAMEDBW-MGD2411-A00 EUDAMEDBW-MGD2318-A32 BW-MGD2318-A96 EUDAMEDBW-MGD2318-A32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975573960027 EUDAMED06975573960041 EUDAMED06975573960003 EUDAMED06975573960034 EUDAMED
- Basic UDI-DI
- 697557396bwyx002MB EUDAMED697557396bwyx004MF EUDAMED697557396bwyx007MM EUDAMED697557396bwyx003MD EUDAMED
- Direct Marketing DI
- 06975573960027 EUDAMED06975573960041 EUDAMED06975573960003 EUDAMED06975573960034 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Beiwo by Hangzhou Beiwo 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
- 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 | 697557396bwyx002MB | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Beiwo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027312
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 1ced0c65-8088-4b9f-bafa-502519afe4f9 61 fields · synced Jul 29, 2026
- EUDAMED 12961c28-4e3b-423c-ae7b-3ebd08954875 61 fields · synced May 16, 2026
- EUDAMED 8f33536a-c70a-4a5a-82fa-97ef293f2138 61 fields · synced May 17, 2026
- EUDAMED 75481daf-226d-44f2-9e52-b18568b06b6c 61 fields · synced May 18, 2026