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Codonics Horizon® XL Multi-media Imager
EUDAMEDFDA UDIClass I (EU MDR)
Ref HZXLModel Horizon Multimedia Dry Imager
Identity
- Trade Name
- Codonics Horizon® XL Multi-media Imager EUDAMEDFDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- Horizon EUDAMEDGrayscale/Color Desktop XL Format Film and Paper Diagnostic Imager FDA UDI
- Model / Reference
- Horizon Multimedia Dry Imager EUDAMEDHZXL EUDAMEDXL FDA UDI
- Description
- Grayscale/Color Desktop XL Format Film and Paper Diagnostic Imager FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905020120 EUDAMEDFDA UDI
- Basic UDI-DI
- 081490502HZMMI01G9 EUDAMED
- Direct Marketing DI
- 00814905020120 EUDAMED
- 510(k) Number
- K060440 FDA UDI
- FDA Product Code
- LMC FDA UDI
- EMDN Code
- Z110706 VIDEO OR DIGITAL BIOIMAGING PLAYERS EUDAMED
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2040 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Codonics Horizon® XL Multi-media Imager by Codonics Inc. — 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 | 081490502HZMMI01G9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Codonics Inc.
- EUDAMED SRN
- US-MF-000008190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED d615908e-fd06-410e-a746-072d324c1f8a 61 fields · synced Jul 30, 2026
- FDA UDI 12adf14b-9c20-4cc9-87d6-0694a07755cb 35 fields · synced May 30, 2026