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Tissue DNA Isolation Kit (Magnetic Bead Method)
EUDAMEDClass A (EU MDR)
Ref SDK60109-48TRef SDK60109D-32TRef SDK60109-96T
Identity
- Trade Name
- Tissue DNA Isolation Kit (Magnetic Bead Method) EUDAMED
- Device Name
- Tissue DNA Isolation Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- SDK60109-48T EUDAMEDSDK60109D-32T EUDAMEDSDK60109-96T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342003425 EUDAMED06973342004354 EUDAMED06973342003418 EUDAMED
- Basic UDI-DI
- 697334200SDK60109KU 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
Tissue DNA Isolation 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 | 697334200SDK60109KU | 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 (3)
- EUDAMED f72a6e0b-760a-4110-a10a-923c75219531 61 fields · synced Jul 30, 2026
- EUDAMED d8af6f47-39a3-4b1c-bd03-1e052638e82f 61 fields · synced May 17, 2026
- EUDAMED 2465ccb9-b3b7-43b8-9e11-ee8f8139cbd6 61 fields · synced May 18, 2026