Identity
- Trade Name
- Avalon FM20 Fetal Monitor EUDAMEDAvalon Fetal Monitor FM20 FDA UDI
- Generic Name
- Foetal/maternal prenatal monitor FDA UDI
- Device Name
- FM20-50 EUDAMEDAvalon FM20 Fetal Monitor for external Fetal Monitoring FDA UDI
- Model / Reference
- 862198 EUDAMEDAvalon FM20 Fetal Monitor FDA UDI
- Description
- Avalon FM20 Fetal Monitor for external Fetal Monitoring FDA UDI
Identifiers
- Catalog Number
- 862198 FDA UDI
- Primary DI / UDI-DI
- 00884838000407 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838000407 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 FM20 Fetal Monitor by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838000407 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 9235f124-c34e-4f84-8145-94f5ed3830cf 61 fields · synced Oct 6, 2026
- FDA UDI 0b5d60a4-0f89-49cd-8654-143ca6c250df 36 fields · synced May 30, 2026