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cfDNA Isolation Kit (Magnetic Beads)
EUDAMEDClass A (EU MDR)
Ref EP120192CERef EP120048CE
Identity
- Trade Name
- cfDNA Isolation Kit (Magnetic Beads) EUDAMED
- Device Name
- cfDNA Isolation Kit (Magnetic Beads) EUDAMED
- Model / Reference
- EP120192CE EUDAMEDEP120048CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975970650088 EUDAMED06975970650071 EUDAMED
- Basic UDI-DI
- 697597065023QJ EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
cfDNA Isolation Kit (Magnetic Beads) by Singlera Genomics (jiangsu) 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 | 697597065023QJ | Class A | Active |
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Manufacturer
- Manufacturer
- Singlera Genomics (jiangsu) Ltd.
- EUDAMED SRN
- CN-MF-000033428
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED acd3c970-3260-41aa-a805-a07f0c40cf55 61 fields · synced Aug 3, 2026
- EUDAMED 4189807f-5f56-4bb8-8974-f2850017444b 61 fields · synced May 18, 2026
- EUDAMED b0a4bc4a-92d5-406d-ab4a-ddc22b29c47c 61 fields · synced Jul 13, 2026
- EUDAMED 0825d8f3-c27c-42d5-8fd5-4853b534cf09 61 fields · synced Aug 3, 2026