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MagaBio plus Whole Blood Genomic DNA Purification Kit
EUDAMEDClass A (EU MDR)
Ref BSC08T1CModel BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08L1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1ERef BSC08L1E-TRef BSC08T1SRef BSC08T1PRef BSC08T1C-CRef BSC08M1E-TRef BSC08S1C-CRef BSC08S1SRef BSC08M1SRef BSC08T1E
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 EUDAMEDBSC08T1C EUDAMEDBSC08L1E-T EUDAMEDBSC08T1S EUDAMEDBSC08T1P EUDAMEDBSC08T1C-C EUDAMEDBSC08M1E-T EUDAMEDBSC08S1C-C EUDAMEDBSC08S1S EUDAMEDBSC08M1S EUDAMEDBSC08T1E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227023 EUDAMED06973843227030 EUDAMED06973843227122 EUDAMED06973843227146 EUDAMED06973843227009 EUDAMED06973843227047 EUDAMED06973843226996 EUDAMED06973843227115 EUDAMED06973843227108 EUDAMED06973843227085 EUDAMED
- Basic UDI-DI
- 697384322BSC08HM EUDAMED
- Direct Marketing DI
- 06973843227023 EUDAMED06973843227030 EUDAMED06973843227122 EUDAMED06973843227146 EUDAMED06973843227009 EUDAMED06973843227047 EUDAMED06973843226996 EUDAMED06973843227115 EUDAMED06973843227108 EUDAMED06973843227085 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.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
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- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- 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 | 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 (10)
- EUDAMED d4feac9e-e4e2-4743-88bd-4fee4ac78f92 61 fields · synced Jul 31, 2026
- EUDAMED 218cd2f1-7ec1-4a96-8512-f48d814a32cf 61 fields · synced May 16, 2026
- EUDAMED 31427d61-5e68-4726-b66c-e4c9222fc8e2 61 fields · synced May 17, 2026
- EUDAMED 7a554e67-ba4c-438e-bf7c-6eebc4c31331 61 fields · synced May 17, 2026
- EUDAMED 64403db6-3091-4ff4-926f-c437c0400123 61 fields · synced May 17, 2026
- EUDAMED b541a4e8-091e-4dd1-a924-0e7ef1f6cbae 61 fields · synced May 18, 2026
- EUDAMED 636c495a-67e0-43ad-bd9c-abdcbba6853a 61 fields · synced May 18, 2026
- EUDAMED c6ad67a9-2130-43f4-8cfb-e459ce8c120e 61 fields · synced May 18, 2026
- EUDAMED f6bc0f9d-a1d4-4926-9ba6-b6e5f65f8e21 61 fields · synced May 18, 2026
- EUDAMED 22711cf5-c48d-418c-b47f-ba920592da9b 61 fields · synced May 18, 2026