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VoyantMark Calibration Device
EUDAMEDFDA UDIClass I (EU MDR)
Ref 54243-13A
by Brainlab SE
Identity
- Trade Name
- VoyantMark Calibration Device EUDAMEDVoyantMark FDA UDI
- Generic Name
- Radiographic image marker, automatic FDA UDI
- Device Name
- Calibration Devices EUDAMED
- Model / Reference
- 54243-13A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 54243-13A FDA UDI
- Primary DI / UDI-DI
- 04056481141394 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Calib.device4T EUDAMED
- Direct Marketing DI
- 04056481141394 EUDAMED
- FDA Product Code
- JAC FDA UDI
- EMDN Code
- Z12139080 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiographic image marker, automatic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1640 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VoyantMark Calibration Device by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481Calib.device4T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 52cf691e-910d-42d0-ae31-74eb33900de0 61 fields · synced Jul 11, 2026
- FDA UDI 74097985-062f-44d4-8708-e68df11a9780 34 fields · synced May 30, 2026