Identity
- Trade Name
- IntraMarX 3D FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
- Model / Reference
- Combo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015518232 FDA UDI
- 510(k) Number
- K201106 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrointestinal telemetric monitoring system capsule, ingestible
IntraMarX 3D by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastrointestinal telemetric monitoring system capsule, ingestible.
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- PillSense Capsule — Enterasense , Ltd. · Class II
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- Heidelberg pH Capsule System — Heidelberg Medical Inc · Class I
- alpHaONE — Chongqing Jinshan Science & Technology (Group) Co., Ltd · Class I
Cleared under the same submission
K201106 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anx Robotica Corp.
Sources (1)
- FDA UDI 2789d80d-0996-433c-808d-a5cef929eb0f 33 fields · synced Jun 8, 2026