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MagPure Circulating DNA Kit
EUDAMEDClass A (EU MDR)
Ref ZEC601-T48(96rxns)Model ZEC601（480rxns）、ZEC601-T48(96rxns)、ZEC601-T96(96rxns)Ref ZEC601-T96(96rxns)
Identity
- Device Name
- MagPure Circulating DNA Kit EUDAMED
- Model / Reference
- ZEC601（480rxns）、ZEC601-T48(96rxns)、ZEC601-T96(96rxns) EUDAMEDZEC601-T48(96rxns) EUDAMEDZEC601-T96(96rxns) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975516220058 EUDAMED06975516220065 EUDAMED
- Basic UDI-DI
- 697551622ZXMCDK2B EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
MagPure Circulating DNA Kit by Xiamen Zhixuan Biotech Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697551622ZXMCDK2B | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Zhixuan Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027993
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 04c53792-ff79-4526-9409-89b1ff134147 61 fields · synced Jul 30, 2026
- EUDAMED 9818984d-771f-49a5-a7b7-8357c3ffc5fc 61 fields · synced May 18, 2026