Identity
- Trade Name
- 3CPM Company, Inc FDA UDI
- Generic Name
- Myoelectric gastrointestinal motility analysis system FDA UDI
- Device Name
- 3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines. FDA UDI
- Model / Reference
- 2.09e FDA UDI
- Description
- 3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864359000223 FDA UDI
- 510(k) Number
- DEN990005 FDA UDI
- FDA Product Code
- MYE FDA UDI
- GMDN Term
- Myoelectric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1735 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Electrocardiograph, professional, single-channelMyoelectric gastrointestinal motility analysis system
3CPM Company, Inc by 3CPM Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 3CPM Company, Inc. — 3CPM Company, Inc. · Class II
- 3CPM Company, Inc. — 3CPM Company, Inc. · Class II
- 3CPM Company, Inc — 3CPM Company, Inc. · Class II
Cleared under the same submission
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
- 3CPM Company, Inc.
Sources (1)
- FDA UDI 0e73eb35-d54e-4497-ba2d-d4964be276d1 34 fields · synced May 30, 2026