← Back to catalogue
1066 MADSEN Astera 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-04-12115Model MADSEN Astera 2Ref 8-04-13129Ref 8-04-12116Ref 8-04-13130Ref 8-04-13123Ref 8-04-13131Ref 8-04-12122Ref 8-04-12419Ref 8-04-13424Ref 8-04-12119Ref 8-04-13126Ref 8-04-13420Ref 8-04-12416Ref 8-04-13121Ref 8-04-13422Ref 8-04-12417Ref 8-04-13120Ref 8-04-13128
Identity
- Trade Name
- 1066 MADSEN Astera 2 EUDAMEDMADSEN Astera 2 FDA UDI
- Generic Name
- Speech audiometer FDA UDI
- Device Name
- 1066 MADSEN Astera 2 EUDAMED1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit FDA UDI
- Model / Reference
- MADSEN Astera 2 EUDAMED8-04-12115 EUDAMED8-04-13129 EUDAMED8-04-12116 EUDAMED8-04-13130 EUDAMED8-04-13123 EUDAMED8-04-13131 EUDAMED8-04-12122 EUDAMED8-04-12419 EUDAMED8-04-13424 EUDAMED8-04-12119 EUDAMED8-04-13126 EUDAMED8-04-13420 EUDAMED8-04-12416 EUDAMED8-04-13121 EUDAMED8-04-13422 EUDAMED8-04-12417 EUDAMED8-04-13120 EUDAMED8-04-13128 EUDAMEDFDA UDI
- Description
- 1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit FDA UDI
Identifiers
- Catalog Number
- 8-04-13128 FDA UDI
- Primary DI / UDI-DI
- 05713315007392 EUDAMED05713315006036 EUDAMED05713315007491 EUDAMED05713315006043 EUDAMED05713315007460 EUDAMED05713315006180 EUDAMED05713315007446 EUDAMED05713315010163 EUDAMED05713315010255 EUDAMED05713315007545 EUDAMED05713315007422 EUDAMED05713315010217 EUDAMED05713315010132 EUDAMED05713315007484 EUDAMED05713315010231 EUDAMED05713315010149 EUDAMED05713315007408 EUDAMED05713315007439 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (19)
- EUDAMED ebf10c5b-f227-4965-b0ee-e98fe2adb138 61 fields · synced Aug 4, 2026
- EUDAMED 81897823-b6f5-4095-93de-28ea9546c560 61 fields · synced May 16, 2026
- EUDAMED ac43caff-d237-4686-a309-fabf854ce018 61 fields · synced May 17, 2026
- EUDAMED cd1c3839-218c-4e58-a048-8853f4ac5051 61 fields · synced May 17, 2026
- EUDAMED 987ace59-36d4-475b-a973-c0d391cebc9f 61 fields · synced May 17, 2026
- EUDAMED 7afb24dc-92e0-4ae5-a8f7-a6c32ef7e097 61 fields · synced May 17, 2026
- EUDAMED 40e7090d-48f5-4aa9-89a2-3a76f0f92272 61 fields · synced May 17, 2026
- EUDAMED c7a42e4f-6b72-4588-8f82-96752876bf66 61 fields · synced May 17, 2026
- EUDAMED 16e5d8bb-27ee-4da0-88e3-339a6468699a 61 fields · synced May 18, 2026
- EUDAMED da96434d-1b42-4406-9cdb-9ccf63005c36 61 fields · synced May 18, 2026
- EUDAMED 08ce76d7-24ae-4103-82cb-2e1eaac840f7 61 fields · synced May 18, 2026
- EUDAMED d09d64d0-1fc0-435f-917e-1b70ec2a941a 61 fields · synced May 18, 2026
- EUDAMED d908a7c6-4bd6-48e2-ba17-827b28da9299 61 fields · synced May 18, 2026
- EUDAMED 29908016-f8f5-4d88-949d-8095ffe7f749 61 fields · synced May 18, 2026
- EUDAMED b3c639a6-569c-4b58-ba32-37d58e3306e7 61 fields · synced May 18, 2026
- EUDAMED 8f2e5725-4a0b-4441-aa07-bba8c062e2d2 61 fields · synced May 18, 2026
- EUDAMED 2c1d820d-d22e-49af-a2dc-a221dbdc921a 61 fields · synced May 19, 2026
- EUDAMED 71ec9067-c156-4ca0-a991-2ba377faed85 61 fields · synced May 19, 2026
- FDA UDI 274e5170-7cbe-4717-9d03-382382caf517 34 fields · synced May 30, 2026