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1077 Madsen Alpha
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-69-41350Model Madsen Alpha
Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- 1077 Madsen Alpha EUDAMED
- Model / Reference
- Madsen Alpha EUDAMED8-69-41350 EUDAMEDAlpha Starter Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315000485 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001004V EUDAMED
- 510(k) Number
- K132957 FDA UDI
- 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
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
Yes
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
1077 Madsen Alpha by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA001004V | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 11612a54-8aec-4094-895a-15bd99fd524f 61 fields · synced Jun 17, 2026
- FDA UDI 874394be-014c-4d71-bdb4-5912d101511c 33 fields · synced May 29, 2026