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Cell Nucleic Acid Extraction Kit (Magnetic Bead Method)
EUDAMEDClass A (EU MDR)
Ref SDK80125R-96TRef SDK80125-96TRef SDK80125R-48TRef SDK80125A-96T
Identity
- Trade Name
- Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) EUDAMED
- Device Name
- Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- SDK80125R-96T EUDAMEDSDK80125-96T EUDAMEDSDK80125R-48T EUDAMEDSDK80125A-96T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342004620 EUDAMED06973342002923 EUDAMED06973342004613 EUDAMED06973342006020 EUDAMED
- Basic UDI-DI
- 697334200SDK80125LG 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) by Jiangsu Bioperfectus Technologies Co., Ltd. — Class A — IVDR — listed in EUDAMED
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 697334200SDK80125LG | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 54938aa5-c2c2-416d-affa-dfc524ee1040 61 fields · synced Aug 1, 2026
- EUDAMED f1cb242a-b604-4788-861a-94252062120b 61 fields · synced May 17, 2026
- EUDAMED b726ebe3-0bf6-4604-83fd-3b9df71eb381 61 fields · synced May 18, 2026
- EUDAMED a3d6502f-303a-46c9-9085-8353606e2b0f 61 fields · synced Aug 1, 2026