Identity
- Trade Name
- Central Monitoring System EUDAMEDFDA UDI
- Generic Name
- Obstetrical monitoring/analysis software FDA UDI
- Device Name
- Central Monitoring System EUDAMED
- Model / Reference
- MFM-CNS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413800236 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138MFMCNSSYZ EUDAMED
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
- GMDN Term
- Obstetrical monitoring/analysis software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Central Monitoring System by Edan Instruments, Inc. — Class IIb — 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 | 69444138MFMCNSSYZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8d77ea38-4654-42d9-84eb-ab57f418a7c2 61 fields · synced Aug 4, 2026
- FDA UDI f1a8ca7b-3812-491f-964f-b6208761d8ba 32 fields · synced May 30, 2026