Identity
- Trade Name
- HIT5 Red EUDAMEDHIT5 EUDAMED
- Device Name
- HITSD Red EUDAMED
- Model / Reference
- HITSD Red EUDAMEDSP006-0013 EUDAMEDSP006-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350005280519 EUDAMED17350005280502 EUDAMED
- Basic UDI-DI
- 735000528HITED EUDAMED
- Direct Marketing DI
- 17350005280519 EUDAMED17350005280502 EUDAMED
- EMDN Code
- Z119010 LASER SYSTEMS FOR PATIENT POSITIONING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Laser patient positioning system
The HIT5 Red medical device is a cutting-edge, standardized positioning system designed to improve the accuracy of surgical procedures. Its advanced algorithm and real-time data analysis enable precise tracking of patient positions during complex operations. With its robust design and user-friendly interface, the HIT5 Red has become a trusted companion for healthcare professionals in various specialties.
Similar devices
Also classified as Laser patient positioning system.
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- Laser Positioning System — Klarity Medical & Equipment（GZ） Co.,Ltd. · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- HIT Laser — C-Rad Positioning AB · Class I
- APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 735000528HITED | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C-RAD Positioning AB
- EUDAMED SRN
- SE-MF-000022326
Sources (2)
- EUDAMED 6c8f4c38-e34e-4e24-960b-62d4f1a403fe 61 fields · synced Aug 1, 2026
- EUDAMED 5c8dcd6c-2152-4d95-adc0-e3323c6fe9ce 61 fields · synced May 18, 2026