Identity
- Trade Name
- ORBIS Clinical Support EUDAMED
- Device Name
- ORBIS Clinical Support EUDAMED
- Model / Reference
- ORBIS Clinical Support EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260693990057 EUDAMED
- Basic UDI-DI
- 426069399OCLINSUPPORTY3 EUDAMED
- Direct Marketing DI
- 04260693990057 EUDAMED
- EMDN Code
- Z120499 GENERAL MEDICINE INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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 Clinical Support 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 | 426069399OCLINSUPPORTY3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DH Healthcare GmbH
- EUDAMED SRN
- DE-MF-000009069
Sources (1)
- EUDAMED 22a4aa0a-6670-44a7-9244-b0e4d77b1d73 61 fields · synced Jul 31, 2026