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Nucleic Automatic Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref GeneReady BSH-32
Identity
- Device Name
- Nucleic Automatic Nucleic Acid Extraction System EUDAMED
- Model / Reference
- GeneReady BSH-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975461700346 EUDAMED
- Basic UDI-DI
- 697546170GeneReadyL3 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Automatic Nucleic Acid Extraction System by Hangzhou Lifereal Biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 697546170GeneReadyL3 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lifereal Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019191
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8d681836-7b60-4bf9-944c-21b83aa948d5 61 fields · synced Jul 13, 2026