Identity
- Trade Name
- Tray - Ø 90x50 mm EUDAMED
- Device Name
- FAMI Processing Basket for the Versius Ultrasonic Dissector Transducer EUDAMED
- Model / Reference
- 231.014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898412948446 EUDAMED
- Basic UDI-DI
- 78995245PBRS6X EUDAMED
- Direct Marketing DI
- 07898412948446 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Category: Instrument tray, reusable
Tray - Ø 90x50 mm by Fábrica de Artefatos Metalúrgicos Itá Ltda. — Class I — 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 | 78995245PBRS6X | Class I | Active |
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Manufacturer
- Manufacturer
- Fábrica de Artefatos Metalúrgicos Itá Ltda.
- EUDAMED SRN
- BR-MF-000039534
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (1)
- EUDAMED 4a66d6ed-bdf2-463f-8711-29024a5d592a 61 fields · synced Jun 18, 2026