Identity
- Trade Name
- Tinearity G1 EUDAMED
- Device Name
- Tinearity EUDAMED
- Model / Reference
- G1 EUDAMED6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350133961000 EUDAMED
- Basic UDI-DI
- 735013396Tinearity1Z5 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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 G1 by Circius Pharma 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 | 735013396Tinearity1Z5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Circius Pharma AB
- EUDAMED SRN
- SE-MF-000013023
Sources (1)
- EUDAMED 85d359bd-d895-48cd-ba3d-6c3fbd877bd6 61 fields · synced Jun 20, 2026