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Tube 12x80 With Red Cap, Sterile, Individually Wrapped
EUDAMEDClass IVD General (EU MDR)
Ref 2E001S01
Identity
- Device Name
- TUBE 12X80 WITH RED CAP, STERILE, INDIVIDUALLY WRAPPED EUDAMED
- Model / Reference
- 2E001S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58053326010533 EUDAMED
- Basic UDI-DI
- B-58053326010533 EUDAMED
- EMDN Code
- W050301020102 SAMPLES ANALYSES, PLASTIC TUBES WITHOUT 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
Tube 12x80 With Red Cap, Sterile, Individually Wrapped by Copan Italia S.P.A. — 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-58053326010533 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (1)
- EUDAMED e0585b47-df67-4b8e-8c77-13cf02e9cb89 61 fields · synced Jun 18, 2026