Identity
- Trade Name
- HIRIS RF43-TS EUDAMEDPRIMAX INTERNATIONAL HIRIS RF43-TS EUDAMED
- Device Name
- HIRIS RF43-TS EUDAMED
- Model / Reference
- HIRIS RF43-TS EUDAMED90 01 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186671034 EUDAMED08055186671041 EUDAMED
- Basic UDI-DI
- B-08055186671034 EUDAMEDB-08055186671041 EUDAMED
- EMDN Code
- Z119007 IMAGE ACQUISITION MODULES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Hiris Rf43-Ts by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — 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-08055186671034 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (2)
- EUDAMED 8ac98684-4ad3-45fd-848d-cee3339236b7 61 fields · synced Oct 6, 2026
- EUDAMED 93e725c5-6f05-4e99-ae70-13d4026c10d7 61 fields · synced May 18, 2026