Identity
- Trade Name
- HIT3 Red EUDAMED
- Device Name
- HITSD Red EUDAMED
- Model / Reference
- HITSD Red EUDAMEDSP006-0012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350005280489 EUDAMED
- Basic UDI-DI
- 735000528HITED EUDAMED
- Direct Marketing DI
- 17350005280489 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
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
Category: Laser patient positioning system
HIT3 Red by C-Rad Positioning Ab — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 735000528HITED | Class I | Active |
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Manufacturer
- Manufacturer
- C-RAD Positioning AB
- EUDAMED SRN
- SE-MF-000022326
Sources (1)
- EUDAMED 13cf7445-3341-488b-999a-4ac4d31b188b 61 fields · synced Jun 18, 2026