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NGS Universal Index Kit (Ion Torrent)
EUDAMEDClass A (EU MDR)
Ref EK003-003-CEModel 24 indexesRef EK003-004-CERef EK004-001-CEModel 5 μL × 24Ref EK003-001-CERef EK003-002-CE
Identity
- Trade Name
- NGS Universal Index Kit (Ion Torrent) EUDAMED
- Model / Reference
- 24 indexes EUDAMEDEK003-003-CE EUDAMEDEK003-004-CE EUDAMED5 μL × 24 EUDAMEDEK004-001-CE EUDAMEDEK003-001-CE EUDAMEDEK003-002-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679048172 EUDAMED06974679048189 EUDAMED06974679048202 EUDAMED06974679048158 EUDAMED06974679048165 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00039W EUDAMED697467904XKUDI0006A4 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
EUDAMEDEUDAMED
NGS Universal Index Kit (Ion Torrent) 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 | 697467904XKUDI00039W | 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 (5)
- EUDAMED fc77c91d-704b-40b1-93cc-5e1cb84b24e2 61 fields · synced Oct 6, 2026
- EUDAMED 4a55cdd3-3f6d-4301-843e-c52a645012dd 61 fields · synced May 17, 2026
- EUDAMED 4b3e0819-4257-402e-ac29-0f160af9f373 61 fields · synced May 18, 2026
- EUDAMED 860f9ddd-0712-410c-bc17-00803cbeab66 61 fields · synced May 18, 2026
- EUDAMED bb0356c3-87fc-4e0b-9818-4cfbde0463a3 61 fields · synced May 18, 2026