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Sigtuple Digital Pathology System with Peripheral Blood Smear Application
EUDAMEDClass A (EU MDR)
Ref Sig/Dev/0015Model AS76 with PBS
Identity
- Device Name
- Sigtuple Digital Pathology System with Peripheral Blood Smear Application EUDAMED
- Model / Reference
- AS76 with PBS EUDAMEDSig/Dev/0015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908018719049 EUDAMED
- Basic UDI-DI
- 8908018719049AS76PBS3Y EUDAMED
- Direct Marketing DI
- 08908018719049 EUDAMED
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Sigtuple Digital Pathology System with Peripheral Blood Smear Application by SigTuple Technologies Pvt Ltd — Class A — IVDR — listed in EUDAMED
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 | 8908018719049AS76PBS3Y | 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 3aed9e27-de14-4845-8bd1-94d3bdb4f51c 61 fields · synced Jul 24, 2026