Identity
- Trade Name
- Tinearity EUDAMED
- Device Name
- Tinearity EUDAMED
- Model / Reference
- G1 EUDAMED6005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136210051 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
Tinearity by Duearity AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 2a5ebbfb-80b0-4fc8-a46b-6c49fbc5c5bc 61 fields · synced May 23, 2026