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Horizon G1
EUDAMEDFDA UDIClass I (EU MDR)
Ref HZG1Model Horizon Multimedia Dry Imager
Identity
- Trade Name
- Horizon G1 EUDAMEDCodonics Horizon® G1 Multi-media Imager FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- Horizon EUDAMEDGrayscale Desktop Large Format Film and Paper Diagnostic Imager, 1 Media Input FDA UDI
- Model / Reference
- Horizon Multimedia Dry Imager EUDAMEDHZG1 EUDAMEDG1 FDA UDI
- Description
- Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 1 Media Input FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905020083 EUDAMEDFDA UDI
- Basic UDI-DI
- 081490502HZMMI01G9 EUDAMED
- Direct Marketing DI
- 00814905020083 EUDAMED
- 510(k) Number
- K021054 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
Horizon G1 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 238c593e-de9e-4bd4-ad2a-83e923a7a3fe 61 fields · synced Jul 10, 2026
- FDA UDI f81f59f9-0bbd-490d-a4a1-ac6f7a1e4313 35 fields · synced May 30, 2026