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MagaBio plus Virus DNA/RNA Purification Kit VI
EUDAMEDClass A (EU MDR)
Ref BSC110M1EModel BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C
Identity
- Trade Name
- MagaBio plus Virus DNA/RNA Purification Kit VI EUDAMED
- Device Name
- MagaBio plus Virus DNA/RNA Purification Kit VI EUDAMED
- Model / Reference
- BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C EUDAMEDBSC110M1E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843225791 EUDAMED
- Basic UDI-DI
- 697384322BSC110FR EUDAMED
- Direct Marketing DI
- 06973843225791 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
MagaBio plus Virus DNA/RNA Purification Kit VI by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 697384322BSC110FR | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 2b642d3f-86e9-417b-9f28-312ad0114ffe 61 fields · synced May 22, 2026