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MagaBio plus Whole Blood Total RNA Purification Kit II
EUDAMEDClass A (EU MDR)
Ref BSC133S1EModel BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-CRef BSC133S1P-ARef BSC133T1ERef BSC133L1E-TRef BSC133T1C-CRef BSC133M1BRef BSC133T1SRef BSC133S1BRef BSC133N1ERef BSC133S1C-CRef BSC133S1SRef BSC133T1C
Identity
- Trade Name
- MagaBio plus Whole Blood Total RNA Purification Kit II EUDAMED
- Device Name
- MagaBio plus Whole Blood Total RNA Purification Kit II EUDAMED
- Model / Reference
- BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-C EUDAMEDBSC133S1E EUDAMEDBSC133S1P-A EUDAMEDBSC133T1E EUDAMEDBSC133L1E-T EUDAMEDBSC133T1C-C EUDAMEDBSC133M1B EUDAMEDBSC133T1S EUDAMEDBSC133S1B EUDAMEDBSC133N1E EUDAMEDBSC133S1C-C EUDAMEDBSC133S1S EUDAMEDBSC133T1C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843223599 EUDAMED06973843229218 EUDAMED06973843223582 EUDAMED06973843223674 EUDAMED06973843223643 EUDAMED06973843229249 EUDAMED06973843229201 EUDAMED06973843229263 EUDAMED06973843223575 EUDAMED06973843223650 EUDAMED06973843229195 EUDAMED06973843223629 EUDAMED
- Basic UDI-DI
- 697384322BSC133G5 EUDAMED
- Direct Marketing DI
- 06973843223599 EUDAMED06973843229218 EUDAMED06973843223582 EUDAMED06973843223674 EUDAMED06973843223643 EUDAMED06973843229249 EUDAMED06973843229201 EUDAMED06973843229263 EUDAMED06973843223575 EUDAMED06973843223650 EUDAMED06973843229195 EUDAMED06973843223629 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
EUDAMEDEUDAMED
Category: Nucleic acid extraction/isolation kit IVD
MagaBio plus Whole Blood Total RNA Purification Kit II by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- 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 | 697384322BSC133G5 | 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 (12)
- EUDAMED ffeae02f-e4cb-4802-90c3-0d3accfdcdfd 61 fields · synced Oct 6, 2026
- EUDAMED 8aaa1896-cb0e-4ef8-b707-583df8f3af3e 61 fields · synced May 17, 2026
- EUDAMED acbc3e5f-e581-4e7e-991f-e06b4b951615 61 fields · synced May 17, 2026
- EUDAMED 81575f59-2545-4fa0-a538-a004e30449d6 61 fields · synced May 17, 2026
- EUDAMED 602ad924-5869-4ccd-ac95-d94b2c2cfc65 61 fields · synced May 17, 2026
- EUDAMED 0db6bcae-e404-410f-a2d7-dafd4286bbb8 61 fields · synced May 18, 2026
- EUDAMED dd36bed4-77a4-4189-81ee-5c8d090ad6bc 61 fields · synced May 18, 2026
- EUDAMED c6d1a9a0-b279-47e5-87d7-b30cfd203758 61 fields · synced May 18, 2026
- EUDAMED 4ec5b24c-0117-41e5-9408-d70204345b89 61 fields · synced May 18, 2026
- EUDAMED ac1d2472-dba7-4802-a126-17477153131e 61 fields · synced May 18, 2026
- EUDAMED 936f6a38-09c1-4bed-a3a6-4c26c93ea485 61 fields · synced May 18, 2026
- EUDAMED 1ef78436-aae7-4e34-9720-896ba11e4483 61 fields · synced May 19, 2026