Identity
- Trade Name
- R-300 EUDAMEDFDA UDI
- Generic Name
- Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
- Device Name
- COLLIMATOR TYPE R-300 EUDAMED
- Model / Reference
- 566-19700-33 EUDAMED566-17970-50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217056453 EUDAMED04540217062447 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217056453 EUDAMEDB-04540217062447 EUDAMED
- 510(k) Number
- K101039 FDA UDI
- FDA Product Code
- IZX FDA UDIIZW FDA UDI
- EMDN Code
- Z11030580 RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1610 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
R-300 by Shimadzu Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217056453 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 7638083f-2242-4ff5-9944-a10df247a951 61 fields · synced Jul 30, 2026
- EUDAMED 7fa038ad-ebf9-4f73-b798-407ee038b603 61 fields · synced May 11, 2026
- FDA UDI f19890d1-4e02-4fd5-a559-4dbec9e4c66b 33 fields · synced May 30, 2026