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AI100 with Shonit
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref Sig/Dev/0001510(k) K221309
Identity
- Trade Name
- AI100 with Shonit EUDAMED
- Device Name
- AI100 with Shonit EUDAMED
- Model / Reference
- Sig/Dev/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908018719018 EUDAMED
- Basic UDI-DI
- 8908018719AI100SHONIT7S EUDAMED
- Direct Marketing DI
- 08908018719018 EUDAMED
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
AI100 with Shonit by SigTuple Technologies Pvt Ltd — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221309 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 8908018719AI100SHONIT7S | Class A | Active |
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Manufacturer
- Manufacturer
- SigTuple Technologies Pvt Ltd
- EUDAMED SRN
- IN-MF-000024400
- FDA Applicant
- Sigtuple Technologies Pvt. , Ltd.
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED b035d3f5-7186-4da0-a70c-a8036e01e23e 85 fields · synced Jun 18, 2026
- FDA 510(k) K221309 1 fields · synced May 18, 2026