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Avalon FM40 Fetal Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 865132
Identity
- Trade Name
- Avalon FM40 Fetal Monitor EUDAMEDAvalon Fetal Monitor FM40 FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- FM20-50 EUDAMEDAvalon FM40 Fetal Monitor for external Fetal Monitoring FDA UDI
- Model / Reference
- 865132 EUDAMEDAvalon FM40 Fetal Monitor FDA UDI
- Description
- Avalon FM40 Fetal Monitor for external Fetal Monitoring FDA UDI
Identifiers
- Catalog Number
- 865132 FDA UDI
- Primary DI / UDI-DI
- 00884838000421 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838000421 EUDAMED
- FDA Product Code
- HGM FDA UDI
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
- GMDN Term
- Foetal/maternal prenatal monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2740 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
MR Unsafe FDA UDI
Avalon FM40 Fetal Monitor by Philips Medizin Systeme Böblingen GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102958 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00884838000421 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (3)
- EUDAMED 3b9ad3d2-2098-4ec9-a618-077b41b28524 61 fields · synced Oct 6, 2026
- FDA UDI 0d15ab65-0ddb-42e6-a6b8-7e88cbc603c7 36 fields · synced May 30, 2026
- FDA 510(k) K102958 1 fields · synced May 18, 2026