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NGS Universal Dual Index Kit(MGI)
EUDAMEDClass A (EU MDR)
Ref EK008-004-CEModel 24 indexes
Identity
- Trade Name
- NGS Universal Dual Index Kit(MGI) EUDAMED
- Device Name
- - EUDAMED
- Model / Reference
- 24 indexes EUDAMEDEK008-004-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679040350 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00119V 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
No
EUDAMED
NGS Universal Dual Index Kit(MGI) 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 | 697467904XKUDI00119V | 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 (1)
- EUDAMED 7f3291d4-fb68-4172-974d-62eb6b833cfd 61 fields · synced Oct 5, 2026