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Biospin Virus DNA/RNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref BSC77L1Model BSC77S1, BSC77M1, BSC77L1Ref BSC77M1
Identity
- Trade Name
- Biospin Virus DNA/RNA Extraction Kit EUDAMED
- Device Name
- Biospin Virus DNA/RNA Extraction Kit EUDAMED
- Model / Reference
- BSC77S1, BSC77M1, BSC77L1 EUDAMEDBSC77L1 EUDAMEDBSC77M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843226248 EUDAMED06973843226378 EUDAMED
- Basic UDI-DI
- 697384322BSC77J8 EUDAMED
- Direct Marketing DI
- 06973843226248 EUDAMED06973843226378 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
Biospin Virus DNA/RNA Extraction Kit by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 697384322BSC77J8 | 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 (2)
- EUDAMED 92945cf6-8122-4f06-969c-5b22a821318b 61 fields · synced Jul 24, 2026
- EUDAMED cd466a9b-6a7f-46c8-916b-ff2cfc67a6f7 61 fields · synced May 18, 2026