Identity
- Trade Name
- Madsen Accuscreen EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- 1077 Madsen Accuscreen EUDAMED
- Model / Reference
- 8-69-41300 EUDAMED"AccuScreen Starter Kit FDA UDI
Identifiers
- Catalog Number
- 8-69-41300 FDA UDI
- Primary DI / UDI-DI
- 05713315004667 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory stimulator
GN Otometrics A/S by Natus Medical Denmark ApS — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Auditory stimulator.
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- Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa
- ER-1 — ETYMOTIC RESEARCH, INC. · Class II
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 a6de39e8-01e3-4387-8c4b-2542ed392778 33 fields · synced Jun 19, 2026
- EUDAMED 4a718b85-5f56-4a76-ac4b-626b59b5c078 61 fields · synced Jun 19, 2026