Identity
- Trade Name
- Odyssey Vision EUDAMEDOdyssey FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Odyssey Quad HD Vision EUDAMEDThe Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab FDA UDI
- Model / Reference
- Quad HD EUDAMEDFDA UDI001-007010-2 EUDAMED
- Description
- The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab FDA UDI
Identifiers
- Catalog Number
- 001-007010-2 FDA UDI
- Primary DI / UDI-DI
- M58800100701020 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M588001007010LH EUDAMED
- FDA Product Code
- DXX FDA UDI
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1290 FDA UDI
- Market of Registration
- Norway 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Odyssey Vision by Stereotaxis, 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 | ++M588001007010LH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2f1595cd-8451-41bc-a810-dc81f92663d5 61 fields · synced Jul 22, 2026
- FDA UDI 8e9177c2-9a61-483f-8b70-9ca6b3814a5b 35 fields · synced May 30, 2026