Identity
- Trade Name
- Madsen AccuScreen EUDAMEDAccuScreen FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- 1077 Madsen Accuscreen EUDAMED1077 AccuScreen ABR/TE/DP FDA UDI
- Model / Reference
- 8-04-13967 EUDAMEDFDA UDI
- Description
- 1077 AccuScreen ABR/TE/DP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315008986 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA0009965 EUDAMED
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory stimulator
AccuScreen by Natus Medical Denmark ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
Sources (2)
- FDA UDI faafbb38-4429-4def-9e37-1aee98dd5086 33 fields · synced Jun 18, 2026
- EUDAMED 5cef2265-2265-42aa-a847-66968d2a220f 61 fields · synced Jun 18, 2026