Identity
- Device Name
- Millennium Helix EUDAMED
- Model / Reference
- 100000137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853023006272 EUDAMED
- Basic UDI-DI
- 0853023006MillHelixTV EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
Millennium Helix by Cerner Corporation — 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 | 0853023006MillHelixTV | Class I | Active |
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Manufacturer
- Manufacturer
- Cerner Corporation
- EUDAMED SRN
- US-MF-000007215
- Authorised Representative
- Oracle Nederland BV NL-AR-000038897
Sources (1)
- EUDAMED 6166a0c8-9378-42b0-90dd-d15163b2f19f 61 fields · synced Jun 18, 2026