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Beiwo
EUDAMEDClass A (EU MDR)
Ref BW-MR6536-A32Model BW-MR6536-A32 BW-MR6536-A96
Identity
- Trade Name
- BEIWO EUDAMED
- Device Name
- Viral DNA/RNA Purification Kit (Beads) EUDAMED
- Model / Reference
- BW-MR6536-A32 BW-MR6536-A96 EUDAMEDBW-MR6536-A32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975573960010 EUDAMED
- Basic UDI-DI
- 697557396bwyx001M9 EUDAMED
- Direct Marketing DI
- 06975573960010 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
Beiwo by Hangzhou Beiwo Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697557396bwyx001M9 | 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 (1)
- EUDAMED 2a202d2c-45c1-442c-be75-9cc5ac43bcee 61 fields · synced Jun 19, 2026