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Eba One
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EBA-5331Model MEASURERS
by Citieffe
Identity
- Trade Name
- SURGICAL INSTRUMENTS (IR) EUDAMEDEBA ONE FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- SURGICAL INSTRUMENTS (IR) EUDAMED
- Model / Reference
- MEASURERS EUDAMEDEBA-5331 EUDAMEDCortical screw ruler FDA UDI
Identifiers
- Catalog Number
- EBA-5331 FDA UDI
- Primary DI / UDI-DI
- 08051739535662 EUDAMEDFDA UDI
- Basic UDI-DI
- 803290962122BQ EUDAMED
- Direct Marketing DI
- 08051739535662 EUDAMED
- 510(k) Number
- K183666 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical ruler, reusable
Eba One by Citieffe — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Citieffe
Sources (2)
- FDA UDI 2564bbf1-f454-458d-9fdf-e45f20c25d40 36 fields · synced Jun 14, 2026
- EUDAMED 510e80e4-60b9-4d88-a3f7-c7a11fcf0e24 61 fields · synced Jun 14, 2026