← Back to catalogue
1096 Madsen Zodiac, QuickCheck Probe Gen 2 Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-35-10001Model 8-04-16030
Identity
- Trade Name
- 1096 Madsen Zodiac, QuickCheck Probe Gen 2 Kit EUDAMEDMadsen Zodiac FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- 1096 Zodiac PC Quick Check (US only) EUDAMED1096 Zodiac Quick Check Probe Gen 2 Kit FDA UDI
- Model / Reference
- 8-04-16030 EUDAMED8-35-10001 EUDAMEDFDA UDI
- Description
- 1096 Zodiac Quick Check Probe Gen 2 Kit FDA UDI
Identifiers
- Catalog Number
- 8-35-10001 FDA UDI
- Primary DI / UDI-DI
- 05713315009907 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, QuickCheck Probe Gen 2 Kit by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Impedance audiometer.
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
- Amplivox — Amplivox, Ltd. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- VIOLA — INVENTIS SRL · Class II
- nanoTymp Set — PATH medical GmbH · Class II
- VIOLA — INVENTIS SRL · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED b75e4a85-847d-4ed7-864a-cf9d56414b0a 61 fields · synced Jun 19, 2026
- FDA UDI 2190a75b-cc1d-4955-b2ac-55e177f117f4 34 fields · synced May 30, 2026