Identity
- Trade Name
- HIT1 Green EUDAMEDHIT1 EUDAMED
- Device Name
- HITSD Red EUDAMED
- Model / Reference
- HITSD Red EUDAMEDSP007-0021 EUDAMEDSP007-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17350005280465 EUDAMED17350005280441 EUDAMED
- Basic UDI-DI
- 735000528HITED EUDAMED
- Direct Marketing DI
- 17350005280465 EUDAMED17350005280441 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
HIT1 Green by C-Rad Positioning Ab — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (2)
- EUDAMED 78f790ee-8cc8-43b1-a5a6-fd9a3073918e 61 fields · synced Jul 21, 2026
- EUDAMED aaddc364-6fc5-40c1-b9ef-6c67f09968bd 61 fields · synced May 18, 2026