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Bk-200
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 566-16400-50Model X-ray Radiography Table BK-200
Identity
- Trade Name
- BK-200 EUDAMEDFDA UDIX-ray Radiography Table BK-200 EUDAMED
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- X-ray Radiography Table BK-200 EUDAMED
- Model / Reference
- 566-16400-50 EUDAMEDX-ray Radiography Table BK-200 EUDAMED566-16404-50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217062591 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217062591 EUDAMED45402170200000000000004U9 EUDAMED
- FDA Product Code
- IXQ FDA UDI
- EMDN Code
- Z11030503 PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- Basic diagnostic x-ray system table, powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 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
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
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
Bk-200 by Shimadzu Corporation — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540217062591 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217062591 | 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 a8559629-75e2-4449-a92a-a375f4ecde20 61 fields · synced Jul 30, 2026
- EUDAMED a184f5a3-68d1-4635-9343-47746c90b151 61 fields · synced May 18, 2026
- FDA UDI a7f2aa44-fb96-471b-894f-f00ad03cc04f 32 fields · synced May 29, 2026