Identity
- Trade Name
- MYCO WELL D‐ONE 32 COMPLETE KIT EUDAMED
- Device Name
- MYCO WELL D‐ONE 32 COMPLETE KIT EUDAMED
- Model / Reference
- MS01321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MS01321PB EUDAMED
- Basic UDI-DI
- B-MS01321PB EUDAMED
- EMDN Code
- W0104080207 MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
Myco Well D‐one 32 Complete Kit by C.p.m. Compagnia Per La Medicina S.r.l. — 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-MS01321PB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C.p.m. Compagnia Per La Medicina S.r.l.
- EUDAMED SRN
- IT-MF-000010738
Sources (1)
- EUDAMED b26421a5-81f8-4c0d-b8e0-d2e20d6ac23b 61 fields · synced Jul 9, 2026