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Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit
EUDAMEDClass B (EU MDR)
Ref G12719Model 25 tests/box
Identity
- Trade Name
- Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit EUDAMED
- Device Name
- Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG12719 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581559 EUDAMED
- Basic UDI-DI
- 697518250G127193L EUDAMED
- Direct Marketing DI
- 06942293581559 EUDAMED
- EMDN Code
- W0102090215 TRICYCLIC ANTIDEPRESSANTS (TOTAL) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Yes
EUDAMED
Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 697518250G127193L | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 0c5f5b35-8bae-48d3-ace6-fbe7ac1aee02 61 fields · synced Oct 6, 2026