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1096 Zodiac PC Diagnostic, Incl. Comfort Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-04-16031Model 8-04-16030
Identity
- Trade Name
- 1096 Zodiac PC Diagnostic, Incl. Comfort Probe EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- 1096 Zodiac PC Quick Check (US only) EUDAMED
- Model / Reference
- 8-04-16030 EUDAMED8-04-16031 EUDAMED1096, PC, DIAGNOSTIC, COM, US FDA UDI
Identifiers
- Catalog Number
- 8-04-16031 FDA UDI
- Primary DI / UDI-DI
- 05713315005558 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
No
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
1096 Zodiac PC Diagnostic, Incl. Comfort Probe by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 eab56ba6-f7ef-4114-91d6-839953142a25 61 fields · synced Jul 8, 2026
- FDA UDI 78098b90-69cf-40f2-8aea-f725493e0638 33 fields · synced May 30, 2026