Identity
- Trade Name
- SAIPH EUDAMEDFDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- SAIPH Bearing EUDAMEDSAIPH Fixed Tibial Bearing Red Left Size D 18mm FDA UDI
- Model / Reference
- SAIPH EUDAMED193-764 EUDAMEDFDA UDI
- Description
- SAIPH Fixed Tibial Bearing Red Left Size D 18mm FDA UDI
Identifiers
- Catalog Number
- 193-764 FDA UDI
- Primary DI / UDI-DI
- 05055455506855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055455506855 EUDAMED
- 510(k) Number
- K140222 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS EUDAMED
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Saiph by MatOrtho Limited — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055455506855 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- MatOrtho Limited
- EUDAMED SRN
- GB-MF-000007614
- Authorised Representative
- MatOrtho Ireland Limited IE-AR-000006856
Sources (2)
- EUDAMED d51b06f0-be7a-47e4-aea3-82c2dc69361f 61 fields · synced Jul 18, 2026
- FDA UDI 214e7a77-ee76-4c8f-8882-542422aa3cdf 35 fields · synced May 30, 2026