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BioTracer™ Dengue Combo Rapid Card
EUDAMEDClass IVD General (EU MDR)
Ref 17311Model BioTracer™ Dengue Combo Rapid Card
Identity
- Trade Name
- BioTracer™ Dengue Combo Rapid Card EUDAMED
- Device Name
- 17311 EUDAMED
- Model / Reference
- BioTracer™ Dengue Combo Rapid Card EUDAMED17311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317541181 EUDAMED
- Basic UDI-DI
- B-08809317541181 EUDAMED
- EMDN Code
- W0105040611 DENGUE VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
BioTracer™ Dengue Combo Rapid Card by NanoEnTek, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809317541181 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED fbbff523-ed75-4246-899e-b55ecfdd4764 61 fields · synced Jul 16, 2026
- EUDAMED bb5e94fb-9308-4dac-9ce5-43af215de98c 61 fields · synced Jul 16, 2026