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3cpm Egg/Evg Respiratory Belt
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3CPM EGG/EVG RSPB Model 3CPM EGG/EVG RESPIRATORY BELT
Identity
- Trade Name
- 3CPM EGG/EVG RESPIRATORY BELT EUDAMED3CPM Company, Inc. FDA UDI
- Generic Name
- Myoelectric gastrointestinal motility analysis system FDA UDI
- Device Name
- RESPIRATORY BELT EUDAMEDRespiratory Belt for 3CPM Electrogastrography system FDA UDI
- Model / Reference
- 3CPM EGG/EVG RESPIRATORY BELT EUDAMED3CPM EGG/EVG RSPB EUDAMED1 FDA UDI
- Description
- Respiratory Belt for 3CPM Electrogastrography system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864359000254 EUDAMEDFDA UDI
- Basic UDI-DI
- 0864359000254EGG954EVGD25 EUDAMED
- 510(k) Number
- DEN990005 FDA UDI
- FDA Product Code
- MYE FDA UDI
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
3cpm Egg/Evg Respiratory Belt 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 | 0864359000254EGG954EVGD25 | 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 497caea5-0f80-4ca5-98ca-0a2197621f08 61 fields · synced Jun 18, 2026
- FDA UDI 4cb81d6d-bcc5-438b-8d70-a053dc05b058 34 fields · synced May 30, 2026