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Simply P Virus DNA/RNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref BSC67M1Model BSC67S1, BSC67M1, BSC67L1Ref BSC67S1Ref BSC67L1
Identity
- Trade Name
- Simply P Virus DNA/RNA Extraction Kit EUDAMED
- Device Name
- Simply P Virus DNA/RNA Extraction Kit EUDAMED
- Model / Reference
- BSC67S1, BSC67M1, BSC67L1 EUDAMEDBSC67M1 EUDAMEDBSC67S1 EUDAMEDBSC67L1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227306 EUDAMED06973843227313 EUDAMED06973843227290 EUDAMED
- Basic UDI-DI
- 697384322BSC67J5 EUDAMED
- Direct Marketing DI
- 06973843227306 EUDAMED06973843227313 EUDAMED06973843227290 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
Simply P 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 | 697384322BSC67J5 | 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 (3)
- EUDAMED 30133116-051b-441a-8f43-825760eabdb8 61 fields · synced Jul 30, 2026
- EUDAMED cfc28218-e999-4c67-bdc6-e6fa5de38f4b 61 fields · synced May 18, 2026
- EUDAMED 5eed8b56-3bad-41ab-9cdd-dbffc4c1f8a9 61 fields · synced May 19, 2026