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1081 Madsen A450
EUDAMEDClass IIa (EU MDR)
Ref 8-04-14667Model Madsen A450Ref 8-04-14668Ref 8-04-14669Ref 8-04-14569
Identity
- Trade Name
- 1081 Madsen A450 EUDAMED
- Device Name
- 1081 Madsen A450 EUDAMED
- Model / Reference
- Madsen A450 EUDAMED8-04-14667 EUDAMED8-04-14668 EUDAMED8-04-14669 EUDAMED8-04-14569 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315010309 EUDAMED05713315010316 EUDAMED05713315010323 EUDAMED05713315007248 EUDAMED
- Basic UDI-DI
- 5713315NA0004258 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
1081 Madsen A450 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 | 5713315NA0004258 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (4)
- EUDAMED 713ace07-67bc-45ba-b327-58b578b6605f 61 fields · synced Jul 24, 2026
- EUDAMED b39a09f7-d477-4836-98f3-f4a0fef5ac14 61 fields · synced May 18, 2026
- EUDAMED de6f619b-498e-4ceb-a01d-a975f892ca9e 61 fields · synced May 19, 2026
- EUDAMED 85f6694a-faea-43a8-b670-7e79014c1cfd 61 fields · synced May 19, 2026