Identity
- Trade Name
- STANDARD™ F200 Analyzer EUDAMED
- Device Name
- STANDARD™ F200 Analyzer EUDAMED
- Model / Reference
- F200 EUDAMED10FA20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111723612 EUDAMED
- Basic UDI-DI
- 88001117IPAA01FA02UK EUDAMED
- Direct Marketing DI
- 08809319399926 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
STANDARD™ F200 Analyzer 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 | 88001117IPAA01FA02UK | 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 d43b940c-9cd2-4ce1-b84e-5e6230b0dfd0 61 fields · synced Jul 22, 2026