Identity
- Device Name
- AI100 with Shrava EUDAMED
- Model / Reference
- Sig/Dev/0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908018719001 EUDAMED
- Basic UDI-DI
- 8908018719AI100SHRAVA6F EUDAMED
- Direct Marketing DI
- 08908018719001 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
AI100 with Shrava by SigTuple Technologies Pvt Ltd — 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 | 8908018719AI100SHRAVA6F | Class A | Active |
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Manufacturer
- Manufacturer
- SigTuple Technologies Pvt Ltd
- EUDAMED SRN
- IN-MF-000024400
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED bad2fa96-5aea-4ebf-b39f-586a790f9c6f 61 fields · synced Jun 18, 2026