Joimax® Intracs® EM Sensor Clip
FDA UDIEUDAMEDClass II (US FDA UDI)
by Joimax, Inc.
Identity
- Trade Name
- Joimax® Intracs® EM Sensor Clip EUDAMEDFDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- joimax® Intracs® EM Sensor Clip EUDAMED
- Model / Reference
- JINTSC2205 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337116592 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371NAVI2SCEK EUDAMED
- Direct Marketing DI
- 04250337116592 EUDAMED
- 510(k) Number
- K192663 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Electromagnetic surgical navigation device tracking 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
Yes
Category: Electromagnetic surgical navigation device tracking system
Joimax® Intracs® EM Sensor Clip by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K192663 also covers:
- Intracs® — JOIMAX, INC.
- Intracs® — JOIMAX, INC.
- Intracs® — JOIMAX, INC.
- Joimax® Intracs® EM Control Unit — JOIMAX, INC.
- Joimax® Intracs® EM Field Generator — JOIMAX, INC.
- Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm — JOIMAX, INC.
- Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clamp — JOIMAX, INC.
- Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clamp — JOIMAX, INC.
- Joimax® Intracs® EM Panel PC — JOIMAX, INC.
- Joimax® Intracs® EM Patient Mapper - AP — JOIMAX, INC.
- Joimax® Intracs® EM Patient Mapper - LAT — JOIMAX, INC.
- Joimax® Intracs® EM Patient Tracker — JOIMAX, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 4178bf54-9c3c-4fc5-b1c2-090b4406bc48 33 fields · synced Jul 28, 2026
- EUDAMED 5534d722-c097-497d-b80e-a563a47221a9 61 fields · synced Jul 28, 2026