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1066 MADSEN Astera 2
EUDAMEDClass IIa (EU MDR)
Ref 8-04-13404Model MADSEN Astera 2
Identity
- Device Name
- 1066 MADSEN Astera 2 EUDAMED
- Model / Reference
- MADSEN Astera 2 EUDAMED8-04-13404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315010200 EUDAMED
- Basic UDI-DI
- 5713315NA000385H EUDAMED
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
1066 MADSEN Astera 2 by Natus Medical Denmark ApS — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA000385H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED ac47a46a-d0f6-4a97-a364-852a3c4dca97 61 fields · synced Jun 19, 2026