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Sample Preservation Buffer
EUDAMEDClass A (EU MDR)
Ref XK-002-CEModel 24 tubes;12 tubes
Identity
- Trade Name
- Sample Preservation Buffer EUDAMED
- Model / Reference
- 24 tubes;12 tubes EUDAMEDXK-002-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974679040374 EUDAMED
- Basic UDI-DI
- 697467904XKUDI00129X 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
Sample Preservation Buffer 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 | 697467904XKUDI00129X | 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 41a82fbf-0eee-4361-9a88-66283beedc0b 61 fields · synced Jul 9, 2026