Identity
- Trade Name
- Distance 3D® Abstandsgewirk-Kissen EUDAMED
- Device Name
- Sitzkissen zur Dekubitusprophylaxe EUDAMED
- Model / Reference
- 110850435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048486114787 EUDAMED
- Basic UDI-DI
- 4048486113901YX EUDAMED
- Direct Marketing DI
- 04048486114787 EUDAMED
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I 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
Distance 3D® Abstandsgewirk-Kissen by Werkmeister GmbH + Co. KG — 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 | 4048486113901YX | Class I | Active |
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Manufacturer
- Manufacturer
- Werkmeister GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005120
Sources (1)
- EUDAMED a4373244-6e1e-455f-bdd1-fe7ae6ed8679 61 fields · synced Jun 18, 2026