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Nucleic Acid Extraction Kit (Magnetic Beads Method)
EUDAMEDClass A (EU MDR)
Ref KY002
Identity
- Trade Name
- Nucleic Acid Extraction Kit (Magnetic Beads Method) EUDAMED
- Device Name
- Nucleic Acid Extraction Kit II (Magnetic Beads Method) EUDAMED
- Model / Reference
- KY002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973131520065 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
Nucleic Acid Extraction Kit (Magnetic Beads Method) by Biobase Scientific (Shandong)Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED f3157dd3-4d33-4e12-95f0-c98226ba77df 61 fields · synced Jul 15, 2026