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Universal Library Preparation Kit
EUDAMEDClass A (EU MDR)
Ref XK-008-24-CEModel 24rxns；96 rxnsRef XK-005-24-CERef XK-013-48-CEModel 48rxnsRef XK-008-96-CE
Identity
- Trade Name
- Universal Library Preparation Kit EUDAMED
- Model / Reference
- 24rxns；96 rxns EUDAMEDXK-008-24-CE EUDAMEDXK-005-24-CE EUDAMED48rxns EUDAMEDXK-013-48-CE EUDAMEDXK-008-96-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679042088 EUDAMED06974679042057 EUDAMED06974679040138 EUDAMED06974679043085 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00019S EUDAMED697467904XKUDI0008A8 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
Universal Library Preparation Kit 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 | 697467904XKUDI00019S | 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 (4)
- EUDAMED c3f16b0d-cf73-4e9e-941d-355b37d13801 61 fields · synced Oct 6, 2026
- EUDAMED cc7fae17-c23b-4b2f-bd87-25a47bc953b8 61 fields · synced May 17, 2026
- EUDAMED de656e5c-66ee-4ec9-bd3c-639700f73a29 61 fields · synced May 18, 2026
- EUDAMED c6ffe998-b4e0-42de-90f6-bae2aaf61ad7 61 fields · synced May 18, 2026