Identity
- Trade Name
- Madsen Accuscreen EUDAMEDNatus FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- 1077 Madsen Accuscreen EUDAMEDAccuScreen Ear Couplers (25 sets of 2) FDA UDI
- Model / Reference
- 8-66-22410 EUDAMEDFDA UDI
- Description
- AccuScreen Ear Couplers (25 sets of 2) FDA UDI
Identifiers
- Catalog Number
- 8-66-22410 FDA UDI
- Primary DI / UDI-DI
- 05713315008641 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA0009965 EUDAMED
- Unit of Use DI
- 05713315008634 EUDAMED
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
- GMDN Term
- Evoked-potential audiometer 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evoked-potential audiometer
Natus 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 3ca062f5-bf86-469e-a0e7-43e17803d2a8 34 fields · synced Aug 3, 2026
- EUDAMED f0788fc1-a74b-42fe-9a67-1b8ed1e2cef4 61 fields · synced Aug 3, 2026