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ROSA Partial Knee Software v1.2.2
EUDAMEDClass IIa (EU MDR)
Ref 20-8020-150-01
by Zimmer CAS
Identity
- Trade Name
- ROSA Partial Knee Software v1.2.2 EUDAMED
- Device Name
- PPK ROSA robot software EUDAMED
- Model / Reference
- 20-8020-150-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00887868578939 EUDAMED
- Basic UDI-DI
- 889024-ZB004121-FE EUDAMED
- EMDN Code
- Z12130492 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
ROSA Partial Knee Software v1.2.2 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-ZB004121-FE | 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 450eb4a3-c7da-4d38-a0ac-37bdada16d55 61 fields · synced Jul 9, 2026