Universal Navigation Adaptor Set
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Universal Navigation Adaptor Set EUDAMEDN/A FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker, reusable FDA UDI
- Device Name
- UNAS Universal Navigation Adaptor Set Navigation Array EUDAMEDUNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY ORANGE 3 SPHERES FDA UDI
- Model / Reference
- UNAS Universal Navigation Adaptor Set Array EUDAMED302015120 EUDAMEDFDA UDI
- Description
- UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY ORANGE 3 SPHERES FDA UDI
Identifiers
- Catalog Number
- 302015120 FDA UDI
- Primary DI / UDI-DI
- 10705034536224 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a000135D EUDAMED
- Direct Marketing DI
- 10705034536224 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical optical-tracking spatial marker, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-purpose stereotactic surgery system
Universal Navigation Adaptor Set by Medos International Sarl — 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 | 0705034a000135D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED a89140a6-d727-4f70-bb54-e65a47539f86 61 fields · synced May 31, 2026
- FDA UDI b454a327-ca71-4a8a-a705-93a3ac78b7f0 36 fields · synced May 29, 2026