Identity
- Trade Name
- AccuScreen EUDAMEDFDA UDIGN Otometrics A/S FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- 1077 Madsen Accuscreen EUDAMED1077 AccuScreen DP FDA UDI
- Model / Reference
- 8-04-13935 EUDAMED8-04-13932 EUDAMED8-04-13901 FDA UDIMADSEN AccuScreen FDA UDIMADSEN AccuScreen, TE FDA UDI
- Description
- 1077 AccuScreen DP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315003974 EUDAMEDFDA UDI05713315005473 EUDAMEDFDA UDI05713315008825 FDA 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 UDIFDA 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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Also classified as Auditory stimulator.
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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 (5)
- FDA UDI b54eeb61-cdea-497a-84b9-3f1f4df9ae93 33 fields · synced Jul 26, 2026
- FDA UDI 97aaad0b-0873-49c5-92b0-6e1f1a540dae 32 fields · synced May 30, 2026
- FDA UDI 95c1a5b7-e5dd-40ee-bd3f-1e4c25e73c77 32 fields · synced May 30, 2026
- EUDAMED a93ab13a-4c93-4f37-8b2b-ecbd109529f2 61 fields · synced Jul 9, 2026
- EUDAMED ed0c2bc8-01b0-4d8d-9f0a-e38d2c9eb9d1 61 fields · synced Jul 26, 2026