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1066 MADSEN Astera 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-04-13127Model MADSEN Astera 2
Identity
- Trade Name
- MADSEN Astera 2 FDA UDI
- Generic Name
- Speech audiometer FDA UDI
- Device Name
- 1066 MADSEN Astera 2 EUDAMED1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit FDA UDI
- Model / Reference
- MADSEN Astera 2 EUDAMED8-04-13127 EUDAMEDFDA UDI
- Description
- 1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit FDA UDI
Identifiers
- Catalog Number
- 8-04-13127 FDA UDI
- Primary DI / UDI-DI
- 05713315007415 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000385H EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Speech audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
1066 MADSEN Astera 2 by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5713315NA000385H | 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 86555cc2-856c-4057-ba63-d21211d566ae 61 fields · synced Jul 9, 2026
- FDA UDI 39668e73-c085-4b82-bd0a-6bc3c89d791f 34 fields · synced May 30, 2026