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Universal Library Preparation Kit
EUDAMEDClass A (EU MDR)
Ref XK-011-48-CEModel 48rxns
Identity
- Trade Name
- Universal Library Preparation Kit EUDAMED
- Model / Reference
- 48rxns EUDAMEDXK-011-48-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679040114 EUDAMED
- Basic UDI-DI
- 697467904XKUDI0008A8 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 | 697467904XKUDI0008A8 | 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 ec28181f-4d86-4504-94fb-3b98b46ceb8d 61 fields · synced Jun 19, 2026