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One Step Tricyclic Antidepressants Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref Strip,Cassette,Panel,Cup
Identity
- Trade Name
- One Step Tricyclic Antidepressants Rapid Test EUDAMED
- Device Name
- One Step Tricyclic Antidepressants Rapid Test EUDAMED
- Model / Reference
- Strip,Cassette,Panel,Cup EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663977753 EUDAMED
- Basic UDI-DI
- B-06939663977753 EUDAMED
- EMDN Code
- W0102160510 TRICYCLIC ANTIDEPRESSANTS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
One Step Tricyclic Antidepressants Rapid Test by Sejoy Biomedical Co., Ltd. — 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-06939663977753 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 26241882-2ad7-494e-b87a-2b126503fb30 61 fields · synced Jun 19, 2026
- EUDAMED 26241882-2ad7-494e-b87a-2b126503fb30-1 61 fields · synced Jun 10, 2026