Identity
- Trade Name
- Madsen Accuscreen EUDAMED
- Device Name
- 1077 Madsen Accuscreen EUDAMED
- Model / Reference
- 8-04-13956 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315010040 EUDAMED
- Basic UDI-DI
- 5713315NA0009965 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Madsen Accuscreen by Natus Medical Denmark ApS — 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 | 5713315NA0009965 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED edbb6a59-b651-47f6-ad30-cb56f55453d7 61 fields · synced Jul 26, 2026