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binx healt Product Number: 5.001.050 Male Urine Specimen Collection Kit
EUDAMEDClass IVD General (EU MDR)
Ref 6E048S.AGL
Identity
- Device Name
- binx healt Product Number: 5.001.050 Male Urine Specimen Collection Kit EUDAMED
- Model / Reference
- 6E048S.AGL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 38053326001537 EUDAMED
- Basic UDI-DI
- B-38053326001537 EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: General specimen collection kit
binx healt Product Number: 5.001.050 Male Urine Specimen Collection Kit by Copan Italia S.P.A. — Class IVD General — IVDD — listed in EUDAMED
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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-38053326001537 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (1)
- EUDAMED ac6b8c8f-9c15-4386-9b60-746f4698eeeb 61 fields · synced Oct 6, 2026