Identity
- Trade Name
- Odyssey Cinema EUDAMED
- Device Name
- Odyssey Cinema EUDAMED
- Model / Reference
- DMS-100 EUDAMED020-007800-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M58802000780040 EUDAMED
- Basic UDI-DI
- ++M588020007800NB EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Odyssey Cinema by Stereotaxis, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M588020007800NB | Class I | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a1ebb23e-972f-4f07-966b-db5cd9392f17 61 fields · synced Jul 25, 2026