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Nucleic Acid Extraction Kit II (Magnetic Beads Method)
EUDAMEDClass A (EU MDR)
Ref KY002
Identity
- Trade Name
- Nucleic Acid Extraction Kit II (Magnetic Beads Method) EUDAMED
- Device Name
- Nucleic Acid Extraction Kit II (Magnetic Beads Method) EUDAMED
- Model / Reference
- KY002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973131520263 EUDAMED06973131521260 EUDAMED06973131520157 EUDAMED06973131521277 EUDAMED06973131520164 EUDAMED06973131520232 EUDAMED06973131520256 EUDAMED06973131520225 EUDAMED06973131520324 EUDAMED06973131520317 EUDAMED06973131520171 EUDAMED06973131520188 EUDAMED
- Basic UDI-DI
- 697313152KY002C7 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
Nucleic Acid Extraction Kit II (Magnetic Beads Method) by Biobase Scientific (Shandong)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
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- 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 | 697313152KY002C7 | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Scientific (Shandong) Co., Ltd
- EUDAMED SRN
- CN-MF-000011660
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (12)
- EUDAMED 8bac3195-6a43-4d34-b6ea-cb1a041479ed 61 fields · synced Aug 4, 2026
- EUDAMED ff313f23-bb66-4d7e-bfa7-2bc780c2b087 61 fields · synced May 17, 2026
- EUDAMED 61e550a7-a5da-4705-ad70-81d230534de0 61 fields · synced May 17, 2026
- EUDAMED c4bfe2dd-1ed7-4c35-9a40-522a2c041451 61 fields · synced May 17, 2026
- EUDAMED e620e8eb-3ded-48f9-9365-95e7f225dccd 61 fields · synced May 17, 2026
- EUDAMED a6fdb96e-1cce-4971-a1f0-fa3373dcf9f7 61 fields · synced May 17, 2026
- EUDAMED e884049f-4649-4420-b3da-c438468e0ba1 61 fields · synced May 17, 2026
- EUDAMED b332af04-3df5-4149-804d-0f74a4ed4b86 61 fields · synced May 19, 2026
- EUDAMED f9238701-a82b-4224-ac06-b1f2a64323c7 61 fields · synced May 19, 2026
- EUDAMED ad1e7c26-baf1-4bb8-8f9f-7e7bbef6f187 61 fields · synced May 19, 2026
- EUDAMED bf0bbc87-03a4-4223-acc1-31365fb7ed9c 61 fields · synced May 19, 2026
- EUDAMED ea8571af-a6cb-4847-9fab-9c13f6761b4d 61 fields · synced May 19, 2026