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MagaBio plus Whole Blood Genomic DNA Purification Kit
EUDAMEDClass A (EU MDR)
Ref BSC08M1BModel BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08L1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E
Identity
- Trade Name
- MagaBio plus Whole Blood Genomic DNA Purification Kit EUDAMED
- Device Name
- MagaBio plus Whole Blood Genomic DNA Purification Kit EUDAMED
- Model / Reference
- BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08L1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E EUDAMEDBSC08M1B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227153 EUDAMED
- Basic UDI-DI
- 697384322BSC08HM EUDAMED
- Direct Marketing DI
- 06973843227153 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 Whole Blood Genomic DNA Purification Kit 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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- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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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 | 697384322BSC08HM | 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 505d7e4a-1281-4992-87a0-1778233e2508 61 fields · synced Jun 20, 2026