Catalyst+
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Catalyst+ EUDAMEDFDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Catalyst+ EUDAMED
- Model / Reference
- Catalyst+ EUDAMEDSP003-0001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350005280762 EUDAMEDFDA UDI
- Basic UDI-DI
- 735000528Catalyst+ZU EUDAMEDB-17350005280762 EUDAMED
- Direct Marketing DI
- 17350005280762 EUDAMED
- 510(k) Number
- K200435 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119010 LASER SYSTEMS FOR PATIENT POSITIONING EUDAMED
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Laser patient positioning system
Catalyst+ by C-Rad Positioning Ab — Class IIb — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 735000528Catalyst+ZU | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K113276 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 735000528Catalyst+ZU | Class IIb | Active |
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Manufacturer
- Manufacturer
- C-RAD Positioning AB
- EUDAMED SRN
- SE-MF-000022326
Sources (4)
- EUDAMED 38ea26d5-472d-46df-a639-db0ac7910371 61 fields · synced Jul 14, 2026
- EUDAMED fea4782e-9fc4-487d-bff0-f5162d9cfcdc 61 fields · synced May 19, 2026
- FDA UDI 8ce11a9b-2440-4c4b-ba15-d040805534ed 34 fields · synced May 30, 2026
- FDA 510(k) K113276 1 fields · synced May 18, 2026