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3cpm Egg/Evg Snap On Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3CPM EGG/EVG SGPModel 3CPM EGG/EVG SNAP ON SOLID GEL FOAM ELECTRODE
Identity
- Trade Name
- 3CPM EGG/EVG SNAP ON ELECTRODE EUDAMED3CPM Company, Inc. FDA UDI
- Generic Name
- Myoelectric gastrointestinal motility analysis system FDA UDI
- Device Name
- EGG/EVG SNAP ON ELECTRODE EUDAMEDDisposable Electrode and Lead Set for use with 3CPM EGG System, 40pk FDA UDI
- Model / Reference
- 3CPM EGG/EVG SNAP ON SOLID GEL FOAM ELECTRODE EUDAMED3CPM EGG/EVG SGP EUDAMED1 FDA UDI
- Description
- Disposable Electrode and Lead Set for use with 3CPM EGG System, 40pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864359000278 EUDAMEDFDA UDI
- Basic UDI-DI
- 0864359000278EGG954EVGD8B EUDAMED
- 510(k) Number
- DEN990005 FDA UDI
- FDA Product Code
- MYE FDA UDI
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Myoelectric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1735 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
3cpm Egg/Evg Snap On Electrode by 3CPM Company, Inc. — Class I — 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 | 0864359000278EGG954EVGD8B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 f56bdacf-2de0-428d-823d-615e058a222c 61 fields · synced Jul 30, 2026
- FDA UDI 2aae4f65-10eb-41e0-8d19-c6a58c482c21 34 fields · synced May 29, 2026