Identity
- Trade Name
- Catalyst+ FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Model / Reference
- SP003 FDA UDI
Identifiers
- Catalog Number
- HY-004 FDA UDI
- Primary DI / UDI-DI
- 17350005280038 FDA UDI
- 510(k) Number
- K200435 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Laser patient positioning system
Catalyst+ by C-Rad Positioning AB — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laser patient positioning system.
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- Catalyst+ PT — C-RAD POSITIONING AB · Class IIb
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- Laser Positioning System — Klarity Medical & Equipment（GZ） Co.,Ltd. · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
Cleared under the same submission
K200435 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- C-Rad Positioning AB
Sources (2)
- FDA UDI 97c1a5e0-5cfd-4626-b5dc-13d7106347cd 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026