Identity
- Trade Name
- DTstream 12L4 EUDAMED
- Device Name
- DTstream EUDAMED
- Model / Reference
- O-DTstream12L4-A-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04660014366354 EUDAMED
- Basic UDI-DI
- 466001436DA03ZQ EUDAMED
- Direct Marketing DI
- 04660014366354 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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
Yes
EUDAMED
New Device
No
EUDAMED
DTstream 12L4 by DNA-Technology, Research & Production, LLC — 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 | 466001436DA03ZQ | Class A | Active |
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Manufacturer
- Manufacturer
- DNA-Technology, Research & Production, LLC
- EUDAMED SRN
- RU-MF-000028223
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2796ccbb-7f87-446c-8f7e-6874edcb0683 61 fields · synced Jul 29, 2026