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Baskets for optics with removable lid – 540x250x70 mm for flexible scopes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 126.312
Identity
- Trade Name
- Baskets for optics with removable lid – 540x250x70 mm for flexible scopes EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- FAMI Processing Basket for the Versius Ultrasonic Dissector Transducer EUDAMED
- Model / Reference
- 126.312 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 126.312 FDA UDI
- Primary DI / UDI-DI
- 07899524533544 EUDAMEDFDA UDI
- Basic UDI-DI
- 78995245PBRS6X EUDAMED
- Direct Marketing DI
- 07899524533544 EUDAMED
- FDA Product Code
- LRP FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Baskets for optics with removable lid – 540x250x70 mm for flexible scopes by Fábrica de Artefatos Metalúrgicos Itá Ltda. — Class I — MDR, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 78995245PBRS6X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 2e39e3c9-9cc4-44c1-b766-8999b7ed308a 61 fields · synced Jun 18, 2026
- FDA UDI fb4c49a2-e3cf-42f6-be5e-e79f47e26ff5 35 fields · synced May 30, 2026