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Catalyst+ HD Ring Gantry
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SP003-0007Model Catalyst+
Identity
- Trade Name
- Catalyst+ HD Ring Gantry EUDAMEDFDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Catalyst+ EUDAMEDCatalyst+ HD Ring Gantry EUDAMED
- Model / Reference
- Catalyst+ EUDAMEDSP003-0007 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350005280786 EUDAMEDFDA UDI
- Basic UDI-DI
- 735000528Catalyst+ZU EUDAMEDB-17350005280786 EUDAMED
- Direct Marketing DI
- 17350005280786 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Catalyst+ HD Ring Gantry by C-Rad Positioning Ab — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 735000528Catalyst+ZU | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 735000528Catalyst+ZU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- C-RAD Positioning AB
- EUDAMED SRN
- SE-MF-000022326
Sources (3)
- EUDAMED b4796ee9-1714-44d6-9689-29a6ef14af60 61 fields · synced Jun 19, 2026
- EUDAMED cfbcfd64-a0ee-4c8b-8bf8-b11f77e5a2a3 61 fields · synced May 17, 2026
- FDA UDI 5f240949-4f39-403a-9659-e2498370b67c 34 fields · synced May 30, 2026