Identity
- Trade Name
- Navident Accessory Kit EUDAMEDFDA UDI
- Generic Name
- Surgical planning/navigation-enhancement system FDA UDI
- Device Name
- Navident Accessory Kit EUDAMEDNavident accessory kit for use with Navident System FDA UDI
- Model / Reference
- 955-ND-ACCK EUDAMEDFDA UDI
- Description
- Navident accessory kit for use with Navident System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955037 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-ND-KITSCP EUDAMED
- FDA Product Code
- PLV FDA UDIQRY FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Surgical planning/navigation-enhancement system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Navident Accessory Kit by Claronav Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 7540209955-ND-KITSCP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClaroNav Inc.
- EUDAMED SRN
- CA-MF-000028837
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5b3eda23-f010-43d0-a514-e64db13e643c 61 fields · synced Jun 8, 2026
- FDA UDI c44f5a6c-e72e-4e71-9c0d-1a8edfc03915 34 fields · synced May 29, 2026