Identity
- Trade Name
- ERG-Thread EUDAMED
- Model / Reference
- ERG-Thread EUDAMEDET-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EFABET012 EUDAMED
- Basic UDI-DI
- ++EFABET01TS EUDAMED
- EMDN Code
- Z12120185 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
ERG-Thread by Fabrinal SA — 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 | ++EFABET01TS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fabrinal SA
- EUDAMED SRN
- CH-MF-000015863
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (1)
- EUDAMED db257268-2cff-403d-aa45-3dcca4cf5cfd 61 fields · synced Jul 12, 2026