Identity
- Trade Name
- ROSA® Recon EUDAMED
- Device Name
- ROSA Recon Platform Group 2 EUDAMED
- Model / Reference
- 20-8020-110-26 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024582682 EUDAMED
- Basic UDI-DI
- 889024-ZB001155-F8 EUDAMED
- EMDN Code
- Z12130401 STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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® Recon by Zimmer CAS — Class I — 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-ZB001155-F8 | Class I | 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 0e5df57d-cdd3-4504-b573-986d729b9ff2 61 fields · synced Jun 19, 2026