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HITSD MRI Red
EUDAMEDClass I (EU MDR)
Ref SP005-0005Model HITSD RedRef SP005-0001
Identity
- Trade Name
- HITSD MRI Red EUDAMEDHITSD Red EUDAMED
- Device Name
- HITSD Red EUDAMED
- Model / Reference
- HITSD Red EUDAMEDSP005-0005 EUDAMEDSP005-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350005280649 EUDAMED17350005280380 EUDAMED
- Basic UDI-DI
- 735000528HITED EUDAMED
- Direct Marketing DI
- 17350005280649 EUDAMED17350005280380 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
HITSD MRI 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 |
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 a8ffa9e6-3374-478b-9a0c-72fb85463e5e 61 fields · synced Jul 12, 2026
- EUDAMED 8207af53-8158-4d80-a4e6-86862525b014 61 fields · synced May 18, 2026