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STANDARD™ M10 Calibration Kit
EUDAMEDClass A (EU MDR)
Ref M10-CAL-01/11CAL10HModel M10-CAL-01
Identity
- Trade Name
- STANDARD™ M10 Calibration Kit EUDAMED
- Device Name
- STANDARD™ M10 Calibration Kit EUDAMED
- Model / Reference
- M10-CAL-01 EUDAMEDM10-CAL-01/11CAL10H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111711350 EUDAMED
- Basic UDI-DI
- 88001117IPAA01MA02W4 EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
Classification
- Device Class
- Class A 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 Calibration Kit by SD Biosensor Inc. — Class A — 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 | 88001117IPAA01MA02W4 | Class A | 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 59596432-62c5-4de2-8dd7-5427c9f9d780 61 fields · synced Jun 19, 2026