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Electrogastrogram / Electroviscerogram
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3CPM EGG/EVG SAMD 001Model 3CPM EGG/EVG 1.0
Identity
- Trade Name
- ELECTROGASTROGRAM / ELECTROVISCEROGRAM EUDAMED3CPM Company, Inc FDA UDI
- Generic Name
- Myoelectric gastrointestinal motility analysis system FDA UDI
- Device Name
- 3CPM EGG/EVG SAMD EUDAMED3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines. FDA UDI
- Model / Reference
- 3CPM EGG/EVG 1.0 EUDAMED3CPM EGG/EVG SAMD 001 EUDAMED2.09e FDA UDI
- Description
- 3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864359000216 EUDAMEDFDA UDI
- Basic UDI-DI
- 0864359000216EGG954EVGDXC EUDAMED
- Direct Marketing DI
- 00864359000216 EUDAMED
- 510(k) Number
- DEN990005 FDA UDI
- FDA Product Code
- MYE FDA UDI
- EMDN Code
- Z120792 GASTROENTEROLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Myoelectric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1735 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electrogastrogram / Electroviscerogram by 3CPM Company, Inc. — Class IIa — 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 | 0864359000216EGG954EVGDXC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- 3CPM Company, Inc.
- EUDAMED SRN
- US-MF-000023973
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 941d7711-0481-4c94-be72-9f4b7cac16b8 61 fields · synced Jun 19, 2026
- FDA UDI 00591be2-b35e-4b62-8066-727e579f35c0 34 fields · synced May 30, 2026