← Back to catalogue
MagaBio plus Virus DNA / RNA Purification Kit Ⅱ
EUDAMEDFDA UDIClass A (EU MDR)
Ref BSC71S1P-AModel BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-TRef BSC71L1SRef BSC71L1E-NRef BSC71M1B-NRef BSC71S1C-NRef BSC71N1ERef BSC71T1CRef BSC71M1E-NRef BSC71S1CRef BSC71N1E-NRef BSC71L1E-T-NRef BSC71S1P-A-NRef BSC71T1S-NRef BSC71S1B-NRef BSC71T1C-C
Identity
- Trade Name
- MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMEDBIOER MagaBio plus Virus DNA/RNA Purification Kit II FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T EUDAMEDBSC71S1P-A EUDAMEDBSC71L1S EUDAMEDFDA UDIBSC71L1E-N EUDAMEDBSC71M1B-N EUDAMEDBSC71S1C-N EUDAMEDBSC71N1E EUDAMEDBSC71T1C EUDAMEDBSC71M1E-N EUDAMEDBSC71S1C EUDAMEDBSC71N1E-N EUDAMEDBSC71L1E-T-N EUDAMEDBSC71S1P-A-N EUDAMEDBSC71T1S-N EUDAMEDBSC71S1B-N EUDAMEDBSC71T1C-C EUDAMED
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843223841 EUDAMED06973843226316 EUDAMED06973843223810 EUDAMED06973843223834 EUDAMED06973843223919 EUDAMED06973843223759 EUDAMED06973843226286 EUDAMED06973843223803 EUDAMED06973843226279 EUDAMED06973843223797 EUDAMED06973843223773 EUDAMED06973843223858 EUDAMED06973843222004 EUDAMED06973843223827 EUDAMED06973843223865 EUDAMED06973843228099 FDA UDI
- Basic UDI-DI
- 697384322BSC71HU EUDAMED
- Direct Marketing DI
- 06973843223841 EUDAMED06973843226316 EUDAMED06973843223810 EUDAMED06973843223834 EUDAMED06973843223919 EUDAMED06973843223759 EUDAMED06973843226286 EUDAMED06973843223803 EUDAMED06973843226279 EUDAMED06973843223797 EUDAMED06973843223773 EUDAMED06973843223858 EUDAMED06973843222004 EUDAMED06973843223827 EUDAMED06973843223865 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MagaBio plus Virus DNA / RNA Purification Kit Ⅱ by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322BSC71HU | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (16)
- EUDAMED 4417421d-5d60-4912-8c76-577e98604d90 61 fields · synced Jul 28, 2026
- EUDAMED af971560-e3d8-4ef6-b7b4-8782be82a507 61 fields · synced May 16, 2026
- EUDAMED ba5648af-7840-43ca-bbd3-304af5a87962 61 fields · synced May 16, 2026
- EUDAMED 53fd4196-b2e3-4115-9e77-75ba307863af 61 fields · synced May 16, 2026
- EUDAMED b630df52-d2d7-4c35-a20f-8c8221b0b211 61 fields · synced May 17, 2026
- EUDAMED 7da40777-1040-4313-be6e-e18a0fdf2593 61 fields · synced May 17, 2026
- EUDAMED e0edcd27-0d93-4c24-9c7e-9c18bba0467b 61 fields · synced May 17, 2026
- EUDAMED c000d0bd-81c0-48c6-b2df-8f8c27830548 61 fields · synced May 17, 2026
- EUDAMED aa3a7afa-ad0c-41a6-ba5e-d0fbd77e7720 61 fields · synced May 17, 2026
- EUDAMED 98929672-1f3d-4503-82b9-d95350e534fa 61 fields · synced May 18, 2026
- EUDAMED dd545c25-15d4-4a86-a7c7-d352a6b5a7bc 61 fields · synced May 18, 2026
- EUDAMED 79457ea0-4932-45b5-8816-e9fb19f21a1f 61 fields · synced May 18, 2026
- EUDAMED a4aaf4d3-2422-442c-8e33-f450d619440d 61 fields · synced May 18, 2026
- EUDAMED c997bd1e-fb18-49cb-a7f6-12de8b4cddb5 61 fields · synced May 19, 2026
- EUDAMED 3569f463-f72a-4e23-b4e4-5cda6f20257d 61 fields · synced May 19, 2026
- FDA UDI 71b817c7-a58a-4f09-94b5-83f57cedee26 33 fields · synced May 29, 2026