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Tinearity
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6000Model G1Ref 6004510(k) K223694
by Duearity AB
Identity
- Trade Name
- Tinearity EUDAMED
- Device Name
- Tinearity EUDAMED
- Model / Reference
- G1 EUDAMED6000 EUDAMED6004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136210006 EUDAMED07350136210075 EUDAMED
- Basic UDI-DI
- 7350136216000UF EUDAMED
- Direct Marketing DI
- 07350136210075 EUDAMED
- 510(k) Number
- K223694 FDA 510(k)
- FDA Product Code
- KLW FDA 510(k)
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3400 FDA 510(k)
- Regulation Number
- 874.3400 FDA 510(k)
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Category: Auditory stimulator
Tinearity by Duearity AB — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223694 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7350136216000UF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Duearity AB
- EUDAMED SRN
- SE-MF-000014586
Sources (3)
- EUDAMED 8a1ffdb5-a6a9-4dd7-b71f-96b53d722ccb 61 fields · synced Jul 24, 2026
- EUDAMED 8a70e72c-3b54-402c-9516-b1f8c483bbb1 61 fields · synced May 17, 2026
- FDA 510(k) K223694 24 fields · synced May 18, 2026