Identity
- Trade Name
- CBC Wash Septa Clip Dx EUDAMED
- Device Name
- CBC Wash Septa Clip, a part of Genetic Analyzer Reagents and Consumables EUDAMED
- Model / Reference
- A66359 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302019736 EUDAMED
- Basic UDI-DI
- 0190302A66359TG EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
CBC Wash Septa Clip Dx by Life Technologies Holdings Pte 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 | 0190302A66359TG | Class A | Active |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED c9e3dafd-f9e4-478e-a95c-1e8f8bdb0e2d 61 fields · synced Jul 27, 2026