Identity
- Trade Name
- MediSpace EUDAMED
- Device Name
- MediSpace EUDAMED
- Model / Reference
- 04061591000479 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061591000479 EUDAMED
- Basic UDI-DI
- 4061591000462RM EUDAMED
- Direct Marketing DI
- 04061591000479 EUDAMED
- EMDN Code
- Z120309 MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb 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
MediSpace by Ondal Medical Systems Gmbh — Class IIb — 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 | 4061591000462RM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ondal Medical Systems GmbH
- EUDAMED SRN
- DE-MF-000000203
Sources (1)
- EUDAMED 05d237af-6f67-4644-9d46-04327f472c46 61 fields · synced Jul 9, 2026