Identity
- Trade Name
- SENSITITRE FRAM2GN EUDAMED
- Device Name
- SENSITITRE FRAM2GN EUDAMED
- Model / Reference
- FRAM2GN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384547944 EUDAMED
- Basic UDI-DI
- 5032384FRAM2GNKZ EUDAMED
- EMDN Code
- W0104080599 MANUAL SUSCEPTIBILITY TESTING - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Sensititre Fram2gn by Trek Diagnostic Systems Ltd — Class B — 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 | 5032384FRAM2GNKZ | Class B | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems Ltd
- EUDAMED SRN
- GB-MF-000016922
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 83a44da8-adb8-4f9d-a058-7911510fc71a 61 fields · synced Jun 19, 2026