Identity
- Device Name
- Capsule Endoscopy Reading Support Software EUDAMED
- Model / Reference
- ProScan EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921010800289 EUDAMED
- Basic UDI-DI
- 69210108PROSC0105007X EUDAMED
- Direct Marketing DI
- 06921010800289 EUDAMED
- EMDN Code
- Z12021292 ENDOSCOPIC CAPSULE SIGNAL RECEIVERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Capsule Endoscopy Reading Support Software by Ankon Technologies Co., Ltd. — 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 | 69210108PROSC0105007X | Class I | Active |
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Manufacturer
- Manufacturer
- ANKON Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000010726
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED e864a3ec-5496-4a3e-9628-00850e3caea3 61 fields · synced Jun 19, 2026