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NGS Universal Index Kit (Illumina)
EUDAMEDClass A (EU MDR)
Ref EK001-001-CEModel 24 indexesRef EK001-004-CE
Identity
- Trade Name
- NGS Universal Index Kit (Illumina) EUDAMED
- Model / Reference
- 24 indexes EUDAMEDEK001-001-CE EUDAMEDEK001-004-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679048110 EUDAMED06974679048141 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00029U EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
NGS Universal Index Kit (Illumina) by Xukang Medical Technology (Suzhou) 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 | 697467904XKUDI00029U | Class A | Active |
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Manufacturer
- Manufacturer
- Xukang Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000017865
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED e14ef26f-b496-4dba-8ee7-d6db1b83fb41 61 fields · synced Oct 6, 2026
- EUDAMED 8d54591d-57c8-44db-bde3-31669f632f35 61 fields · synced May 18, 2026