Identity
- Trade Name
- Madsen Accuscreen EUDAMED
- Device Name
- 1077 Madsen Accuscreen EUDAMED
- Model / Reference
- 8-04-13955 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315010033 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
Category: Auditory stimulator
Madsen Accuscreen by Natus Medical Denmark ApS — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Auditory stimulator.
- Protektor32 Pods and Pod Kit — NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) · Class I
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Nucleus — Cochlear · Class III
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Protektor32 Pods and Pod Kit — NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) · Class I
- ER-1 — ETYMOTIC RESEARCH, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED 937fae69-e98b-4aff-88ca-87e89ddd10d2 61 fields · synced Jul 16, 2026