Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- [ARVIS] Eyepiece Assembly EUDAMEDARVIS Eyepiece FDA UDI
- Model / Reference
- IN-12400 EUDAMEDFDA UDI
- Description
- ARVIS Eyepiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350594 EUDAMEDFDA UDI
- Basic UDI-DI
- 08889120000Z120114800A1FX EUDAMED
- Direct Marketing DI
- 00810180350594 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany 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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Neurological stereotactic surgery system
[ARVIS] Eyepiece Assembly by Kico Knee Innovation Company Pty Ltd — 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 | 08889120000Z120114800A1FX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kico Knee Innovation Company Pty Ltd
- EUDAMED SRN
- AU-MF-000011477
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 1154c7cc-9468-4ffe-b36c-21f617aedcc4 61 fields · synced Aug 2, 2026
- FDA UDI cdcb1075-526a-437f-96c8-eed5bb0e678e 33 fields · synced May 30, 2026