Identity
- Trade Name
- ORBIS ICU-Manager EUDAMED
- Device Name
- ORBIS ICU-Manager EUDAMED
- Model / Reference
- ORBIS ICU-Manager EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260693990156 EUDAMED04260693990002 EUDAMED
- Basic UDI-DI
- 426069399OICUMANAGERFW EUDAMED
- Direct Marketing DI
- 04260693990156 EUDAMED04260693990002 EUDAMED
- EMDN Code
- Z120499 GENERAL MEDICINE INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
ORBIS ICU-Manager by DH Healthcare GmbH — Class IIa — 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 | 426069399OICUMANAGERFW | Class IIa | Active |
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Manufacturer
- Manufacturer
- DH Healthcare GmbH
- EUDAMED SRN
- DE-MF-000009069
Sources (2)
- EUDAMED 1c954d98-5554-4a7e-a815-04b8cec61c0f 61 fields · synced Jul 24, 2026
- EUDAMED 077357cd-c994-4f97-a14c-a53245d2a309 61 fields · synced May 17, 2026