Identity
- Trade Name
- Tinearity EUDAMEDTinearity Adapters FDA UDI
- Generic Name
- Bone-conduction tinnitus masker FDA UDI
- Device Name
- Tinearity EUDAMED
- Model / Reference
- G1 EUDAMEDFDA UDI6042 EUDAMED
Identifiers
- Catalog Number
- 6042 FDA UDI
- Primary DI / UDI-DI
- 07350136210020 EUDAMEDFDA UDI
- Basic UDI-DI
- 7350136216000UF EUDAMED
- 510(k) Number
- K223694 FDA UDI
- FDA Product Code
- KLW FDA UDI
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
- GMDN Term
- Bone-conduction tinnitus masker FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tinearity by Duearity AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 7350136216000UF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Duearity AB
- EUDAMED SRN
- SE-MF-000014586
Sources (2)
- EUDAMED b666df8d-0501-41c0-95e3-c59f2c1cdab7 61 fields · synced Jul 11, 2026
- FDA UDI e6cd1bff-14af-4161-9c06-2001415db088 34 fields · synced May 29, 2026