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Fetal & Maternal Monitor
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref F15Ref F12510(k) K173042Ref FECG1Ref F12 AirRef F15 Air
Identity
- Trade Name
- Fetal & Maternal Monitor EUDAMED
- Device Name
- Fetal & Maternal Monitor EUDAMED
- Model / Reference
- F15 EUDAMEDF12 EUDAMEDFECG1 EUDAMEDF12 Air EUDAMEDF15 Air EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413811966 EUDAMED06944413819153 EUDAMED06944413814318 EUDAMED06944413819160 EUDAMED06944413811973 EUDAMED
- Basic UDI-DI
- 69444138F15SNQ EUDAMED69444138F12SNF EUDAMED69444138FECG1MJ EUDAMED
- 510(k) Number
- K173042 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Fetal & Maternal Monitor by Edan Instruments, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173042 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69444138F15SNQ | Class IIb | Active |
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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 (6)
- EUDAMED 67eb44c4-208c-4821-a42a-af4f74d1bdbd 61 fields · synced Oct 6, 2026
- EUDAMED 79d9597d-3aeb-4a79-bdb3-6e78741f03dc 61 fields · synced May 17, 2026
- FDA 510(k) K173042 24 fields · synced May 18, 2026
- EUDAMED c0f277b1-756c-495b-b571-e7e7fc702da0 61 fields · synced Jul 12, 2026
- EUDAMED 73e4664b-9bab-4f0f-aadf-fab494089d9f 61 fields · synced Jul 13, 2026
- EUDAMED 014ae7e4-ab8a-45cf-b237-e0911c82529c 61 fields · synced Jul 25, 2026