Identity
- Trade Name
- STANDARD™ M10 MRSA/SA EUDAMED
- Device Name
- STANDARD™ M10 MRSA/SA EUDAMED
- Model / Reference
- M10-MRSA-01 EUDAMED11MSS10A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111722219 EUDAMED
- Basic UDI-DI
- 88001117IPCA01MA22XG EUDAMED
- EMDN Code
- W0105011203 STAPHYLOCOCCAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Standard™ M10 Mrsa/Sa by SD Biosensor Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 88001117IPCA01MA22XG | Class C | Active |
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Manufacturer
- Manufacturer
- SD Biosensor Inc.
- EUDAMED SRN
- KR-MF-000009168
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 0b7b76a5-3bae-48fc-8535-529f7d587f84 61 fields · synced Jun 19, 2026