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Electrogastrogam(EGG)/Electroviscerogram(EVG)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EGG/EVG-OUSModel 3CPM Electrogastrogram/Electroviscerogram
Identity
- Trade Name
- Electrogastrogam(EGG)/Electroviscerogram(EVG) EUDAMED3CPM Company, Inc. FDA UDI
- Generic Name
- Myoelectric gastrointestinal motility analysis system FDA UDI
- Device Name
- 3CPM Electrogastrography/Electroviscerography System EUDAMEDHuman Interface Device FDA UDI
- Model / Reference
- 3CPM Electrogastrogram/Electroviscerogram EUDAMEDEGG/EVG-OUS EUDAMED1.02 FDA UDI
- Description
- Human Interface Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864359000230 EUDAMEDFDA UDI
- Basic UDI-DI
- 086435900023EGG200EVGRX EUDAMED
- Direct Marketing DI
- 00864359000230 EUDAMED
- 510(k) Number
- DEN990005 FDA UDI
- FDA Product Code
- MYE FDA UDI
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER 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
- Market of Registration
- Denmark 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
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
Electrogastrogam(EGG)/Electroviscerogram(EVG) 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 | 086435900023EGG200EVGRX | 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 52cf5231-de48-44cc-840e-4c2dff356c4b 61 fields · synced Jun 20, 2026
- FDA UDI a978237e-07f9-4df1-977e-e2bcfba61819 34 fields · synced May 30, 2026