Identity
- Trade Name
- Fetal monitor FDA UDI
- Generic Name
- Foetal cardiac monitor FDA UDI
- Model / Reference
- FM-2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413807723 FDA UDI
- FDA Product Code
- HGM FDA UDIHGL FDA UDI
- GMDN Term
- Foetal cardiac monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 FDA UDI884.2960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Foetal cardiac monitor
Fetal monitor by Edan Instruments, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Foetal cardiac monitor.
- Compact FM — Avante · Class II
- FC700 — Bionet Company, Ltd. · Class II
- ADVANCED FETAL MONITOR — ADVANCED INSTRUMENTATIONS, INC. · Class II
- Compact Plus — Avante · Class II
- Compact Plus — Avante · Class II
- Compact Plus — Avante · Class II
- FC1400 — Bionet Company, Ltd. · Class II
- Compact Plus — Avante · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
Sources (2)
- FDA UDI 4bc4a094-6702-4593-aa23-86f6c0f3fc74 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026