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Rosa® Knee Inst Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20-8020-063-00Ref 20-8020-191-00Ref 20-8020-190-00Ref 20-8020-192-00
by Zimmer CAS
Identity
- Trade Name
- ROSA® KNEE INST CASE EUDAMEDFDA UDIROSA® Knee EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDIMedical capital equipment storage bag/case FDA UDI
- Device Name
- ROSA robot – Instruments Class I - Group 4 EUDAMEDROSA robot system Group 1 – Instruments Class IIa EUDAMED
- Model / Reference
- 20-8020-063-00 EUDAMEDFDA UDI20-8020-190-00 EUDAMEDFDA UDI20-8020-191-00 EUDAMEDFDA UDI20-8020-192-00 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20-8020-190-00 FDA UDI20-8020-063-00 FDA UDI20-8020-191-00 FDA UDI20-8020-192-00 FDA UDI
- Primary DI / UDI-DI
- 00889024516786 EUDAMEDFDA UDI00887868552199 EUDAMEDFDA UDI00887868552205 EUDAMEDFDA UDI00887868552212 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB001157-FE EUDAMED889024-ZB001154-F5 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDIMedical capital equipment storage bag/case FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Multi-purpose stereotactic surgery system
Rosa® Knee Inst Case 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
European Union Active
CE/MDR
United States Pending data
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 (8)
- EUDAMED e0254da0-e828-4732-9b52-275430548ba6 61 fields · synced Jul 29, 2026
- FDA UDI 2a5c50d3-e413-464a-8c74-e53c788702cc 36 fields · synced May 29, 2026
- FDA UDI 679fe473-65d5-4487-864a-d8d3b9d71db8 35 fields · synced May 30, 2026
- FDA UDI 6f8f97a0-29d6-435f-bf95-d4d7419f5a7d 36 fields · synced May 30, 2026
- FDA UDI f8211551-3ea1-4f4b-b097-8f4b6476e945 36 fields · synced May 30, 2026
- EUDAMED fba8b757-603a-457c-a807-ad990cde2961 61 fields · synced Jul 10, 2026
- EUDAMED 421ca3e4-aff4-499d-b20f-fb4dc4daf564 61 fields · synced Jul 10, 2026
- EUDAMED 63f88e04-b37d-4336-884b-1294348d5a2f 61 fields · synced Jul 29, 2026