TAU Model 1000-0016 Mini C-Arm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Orthoscan TAU Mini C-Arm 1515 EUDAMEDTAU Model 1000-0016 Mini C-Arm FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Orthoscan Mini C-arm X-ray System EUDAMEDImage-Intensified Fluoroscopic X-Ray System, Mobile FDA UDI
- Model / Reference
- 1000-0016 EUDAMEDFDA UDIOrthoscan Mini C-arm X-ray System EUDAMED
- Description
- Image-Intensified Fluoroscopic X-Ray System, Mobile FDA UDI
Identifiers
- Primary DI / UDI-DI
- B225100000160 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B225XRAYSYSTEMLH EUDAMED
- Direct Marketing DI
- B225100000160 EUDAMED
- FDA Product Code
- OXO FDA UDIJAA FDA UDIMQB FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI892.1680 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Portable general-purpose fluoroscopic x-ray system, digital
TAU Model 1000-0016 Mini C-Arm by Ziehm-Orthoscan, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Ziehm-Orthoscan, Inc.
Sources (2)
- FDA UDI e03b79c2-26d3-468d-8734-eb68b885a7e9 35 fields · synced Aug 1, 2026
- EUDAMED da851433-ec70-4634-8f80-07b4cdb240e5 61 fields · synced Aug 1, 2026