Rosa® Knee Nexgen® Id Plate
EUDAMEDFDA UDIClass I (EU MDR)
by Zimmer CAS
Identity
- Trade Name
- ROSA® KNEE NEXGEN® ID PLATE EUDAMEDFDA UDI
- Generic Name
- Device operating status label/tag, reusable FDA UDI
- Device Name
- ROSA robot – Instruments Class I - Group 4 EUDAMED
- Model / Reference
- 20-8020-061-01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20-8020-061-01 FDA UDI
- Primary DI / UDI-DI
- 00889024516816 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB001157-FE EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Device operating status label/tag, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-purpose stereotactic surgery system
Rosa® Knee Nexgen® Id Plate by Zimmer CAS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024-ZB001157-FE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 9740df08-497f-4c40-be93-a17c9262b33a 61 fields · synced Oct 5, 2026
- FDA UDI 37f4be9b-816b-4df7-9bb9-a889b1f5f75f 34 fields · synced May 30, 2026