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Rosa Stabilizer Tissue Deflector 60mm
EUDAMEDClass IIa (EU MDR)
Ref 20-8020-040-00
by Zimmer CAS
Identity
- Trade Name
- ROSA STABILIZER TISSUE DEFLECTOR 60MM EUDAMED
- Device Name
- ROSA robot system Group 1 – Instruments Class IIa EUDAMED
- Model / Reference
- 20-8020-040-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889024674806 EUDAMED
- Basic UDI-DI
- 889024-ZB001154-F5 EUDAMED
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
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 Stabilizer Tissue Deflector 60mm 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-ZB001154-F5 | 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 987ba148-1e39-4db7-978a-f6713a53f4aa 61 fields · synced Jul 10, 2026