Identity
- Trade Name
- STANDARD™ i TSH EUDAMED
- Device Name
- STANDARD™ i TSH EUDAMED
- Model / Reference
- i-TSH-01 EUDAMED16TSH10F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111722042 EUDAMED
- Basic UDI-DI
- 88001117IPBA01IA12VW EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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™ i TSH by SD Biosensor Inc. — Class B — 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 | 88001117IPBA01IA12VW | Class B | 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 f9809436-62bf-49e0-a7d9-fb4eca92c987 61 fields · synced Jul 16, 2026