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Hair Benzoylecgonine (BE) Test Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref SUPF057025
Identity
- Trade Name
- Hair Benzoylecgonine (BE) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Hair Benzoylecgonine (BE) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- SUPF057025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521005629 EUDAMED
- Basic UDI-DI
- B-06974521005629 EUDAMED
- EMDN Code
- W0102090106 COCAINE + COCAINE METABOLITES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Hair Benzoylecgonine (BE) Test Kit (Fluorescence Immunochromatographic Assay) by Shenzhen Superbio Technology Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974521005629 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 5782e767-9b3a-42e2-9373-8416cc50910c 61 fields · synced Jun 19, 2026