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Pre-amplification Buffer Kit (MGI)
EUDAMEDClass A (EU MDR)
Ref EK100806224-CEModel 24rxns；48 rxnsRef EK100806248-CE
Identity
- Trade Name
- Pre-amplification Buffer Kit (MGI) EUDAMEDPre-amplification Buffer Kit(MGI) EUDAMED
- Device Name
- - EUDAMED
- Model / Reference
- 24rxns；48 rxns EUDAMEDEK100806224-CE EUDAMEDEK100806248-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679040305 EUDAMED06974679040312 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00109T 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
Pre-amplification Buffer 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 | 697467904XKUDI00109T | 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 (2)
- EUDAMED 78deab56-d32d-4628-bb98-1ab4e37030b2 61 fields · synced Oct 6, 2026
- EUDAMED 9810d41f-512c-462f-aa54-324d3afce529 61 fields · synced May 18, 2026