Identity
- Trade Name
- 3500 Dx Series 8-Strip Septa EUDAMED
- Device Name
- 8-Strip/384-Well Septa, a part of Genetic Analyzer Reagents and Consumables EUDAMED
- Model / Reference
- 4410702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302007382 EUDAMED
- Basic UDI-DI
- 019030244106079M 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
3500 Dx Series 8-Strip Septa 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 | 019030244106079M | 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 4ab4df72-69af-47e3-9a96-dc6f322d0204 61 fields · synced Jun 19, 2026