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ChromInst™ Universal Library Normalization Kit (Illumina)
EUDAMEDClass A (EU MDR)
Ref EK100802348-CEModel 48 rxns
Identity
- Trade Name
- ChromInst™ Universal Library Normalization Kit (Illumina) EUDAMED
- Model / Reference
- 48 rxns EUDAMEDEK100802348-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679048226 EUDAMED
- Basic UDI-DI
- 697467904XKUDI0007A6 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
ChromInst™ Universal Library Normalization Kit (Illumina) by Xukang Medical Technology (Suzhou) Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697467904XKUDI0007A6 | 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 f1826a38-f349-4977-b819-63a27e7a6076 61 fields · synced Oct 6, 2026