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Hybridization Capture of DNA libraries Kit V2.0(MGI)
EUDAMEDClass A (EU MDR)
Ref KT100809424-CEModel 24 rxns
Identity
- Trade Name
- Hybridization Capture of DNA libraries Kit V2.0(MGI) EUDAMED
- Device Name
- - EUDAMED
- Model / Reference
- 24 rxns EUDAMEDKT100809424-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679040541 EUDAMED
- Basic UDI-DI
- 697467904XKUDI0016A7 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
Hybridization Capture of DNA libraries Kit V2.0(MGI) 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 | 697467904XKUDI0016A7 | 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 3efdba8c-09f1-4ff2-9987-5a1cc60efd6f 61 fields · synced Jun 18, 2026