Identity
- Trade Name
- ROSA® Knee EUDAMED
- Device Name
- ROSA robot software - Group 3 EUDAMED
- Model / Reference
- 20-8020-130-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024687455 EUDAMED
- Basic UDI-DI
- 889024-ZB001156-FB EUDAMED
- EMDN Code
- Z12130492 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
ROSA® Knee by Zimmer CAS — 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 | 889024-ZB001156-FB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zimmer CAS
- EUDAMED SRN
- CA-MF-000000791
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (1)
- EUDAMED 3ce4e863-b816-4f79-b291-dd19c2fae763 61 fields · synced May 23, 2026