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1096 Madsen Zodiac Diagnostic Probe Gen 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 36433Model 8-04-16030
Identity
- Trade Name
- 1096 Madsen Zodiac Diagnostic Probe Gen 2 EUDAMEDMadsen Zodiac FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- 1096 Zodiac PC Quick Check (US only) EUDAMED1096 Zodiac Diagnostic Probe Gen 2 FDA UDI
- Model / Reference
- 8-04-16030 EUDAMED36433 EUDAMED036433 FDA UDI
- Description
- 1096 Zodiac Diagnostic Probe Gen 2 FDA UDI
Identifiers
- Catalog Number
- 036433 FDA UDI
- Primary DI / UDI-DI
- 05713315009389 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001024Z EUDAMED
- FDA Product Code
- ETY FDA UDI
- EMDN Code
- Z12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM EUDAMED
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1090 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Impedance audiometer
1096 Madsen Zodiac Diagnostic Probe Gen 2 by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 5713315NA001024Z | 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 7a5ae4bf-35d7-4ea0-b82c-f9111dc2d182 61 fields · synced Jun 18, 2026
- FDA UDI bbfa7d3b-472c-49c3-9bc7-8f8ca7687608 34 fields · synced May 30, 2026