Identity
- Trade Name
- FH-21HR EUDAMEDFDA UDI
- Generic Name
- X-ray system tube support, floor standing FDA UDI
- Device Name
- X-RAY TUBE STAND FH-21HR EUDAMED
- Model / Reference
- 563-43000-55 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217062362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217062362 EUDAMED
- FDA Product Code
- IYB FDA UDI
- EMDN Code
- Z11030501 COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- X-ray system tube support, floor standing FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1770 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fh-21hr 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-04540217062362 | 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 (2)
- EUDAMED f5bd52de-cba6-4911-b3b1-8030cf90b9a1 61 fields · synced Jul 26, 2026
- FDA UDI c03448e5-0613-4d39-9dde-35a55c34d6d1 32 fields · synced May 30, 2026