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Nucleic Acid Purification Kit
EUDAMEDClass A (EU MDR)
Ref USCI-CH001Model Package specification: 96 tests/kit
Identity
- Device Name
- Nucleic Acid Purification Kit EUDAMED
- Model / Reference
- Package specification: 96 tests/kit EUDAMEDUSCI-CH001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975467551041 EUDAMED
- Basic UDI-DI
- 697546755104PK EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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 Purification Kit by Beijing USCI Medical Devices 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 | 697546755104PK | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing USCI Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000026308
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 94e282ac-5f5f-4a77-81ca-c16007f5ba14 61 fields · synced Jun 18, 2026