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mediSIGHT / HEYEX EMR PCR Risk Calculator
EUDAMEDClass I (EU MDR)
Ref N/AModel v2
Identity
- Device Name
- mediSIGHT / HEYEX EMR PCR Risk Calculator EUDAMED
- Model / Reference
- v2 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01-PCRSY EUDAMED
- Basic UDI-DI
- B-01-PCRSY EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
mediSIGHT / HEYEX EMR PCR Risk Calculator by Medisoft Limited — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-01-PCRSY | Class I | Active |
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Manufacturer
- Manufacturer
- Medisoft Limited
- EUDAMED SRN
- GB-MF-000035080
- Authorised Representative
- MedicalCommunications GmbH DE-AR-000034332
Sources (1)
- EUDAMED eef7ddba-98e7-4b7d-9e62-8ad09e91f6b8 61 fields · synced Jul 11, 2026