Identity
- Trade Name
- Tinearity EUDAMED
- Device Name
- Tinearity EUDAMED
- Model / Reference
- G1 EUDAMED6001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136210044 EUDAMED
- Basic UDI-DI
- 7350136216000UF EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7350136216000UF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Duearity AB
- EUDAMED SRN
- SE-MF-000014586
Sources (1)
- EUDAMED 703400a6-30bc-4b78-b8c0-63f7b1173f98 61 fields · synced May 23, 2026