Identity
- Trade Name
- Inoculation Loops EUDAMED
- Device Name
- SOFT LOOP 1 ul STERILE, IN RESEALABLE BAGS OF 40 PCS EUDAMED
- Model / Reference
- 612-9361 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-612-93618C EUDAMED
- Basic UDI-DI
- B-612-93618C EUDAMED
- EMDN Code
- W05030302 MICROBIOLOGICAL CULTURE, LOOPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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: Inoculating tool IVD, manual
Inoculation Loops by Copan Italia S.P.A. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Inoculating tool IVD, manual.
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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 | B-612-93618C | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (1)
- EUDAMED dcbc6949-8ebd-40c2-be12-4ac397b02086 61 fields · synced Oct 6, 2026