Identity
- Trade Name
- BeaverBeads™ Circulating DNA Kit EUDAMED
- Device Name
- BeaverBeads™ Circulating DNA Kit EUDAMED
- Model / Reference
- 70404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975115120117 EUDAMED
- Basic UDI-DI
- 69751151270404WB 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
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
BeaverBeads™ Circulating DNA Kit by BEAVER Biomedical Engineering Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69751151270404WB | Class A | Active |
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Manufacturer
- Manufacturer
- BEAVER Biomedical Engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000020632
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED b85b7bca-0d3d-4efb-b527-c061b0b23016 61 fields · synced Jun 20, 2026