Identity
- Trade Name
- CaptureITPro EUDAMED
- Device Name
- CAPTUREITPRO MEDICAL IMAGING SOFTWARE EUDAMED
- Model / Reference
- ASITKTB1HDEX3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020602100 EUDAMED
- Basic UDI-DI
- 8908020602CPV24D EUDAMED
- Direct Marketing DI
- 08908020602100 EUDAMED
- EMDN Code
- Z12020492 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CaptureITPro by AmbalSoft InfoTech Private Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8908020602CPV24D | Class I | Active |
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Manufacturer
- Manufacturer
- AmbalSoft InfoTech Private Limited
- EUDAMED SRN
- IN-MF-000029308
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 22dd81c1-27de-4f8f-ae6a-88ee0efde162 61 fields · synced Jun 18, 2026