Identity
- Trade Name
- Avalon CL Fetal & Maternal Pod EUDAMEDFDA UDI
- Generic Name
- Tocodynamometer probe FDA UDI
- Device Name
- Fetal Transducers and Pods EUDAMEDThe Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074. FDA UDI
- Model / Reference
- 866488 EUDAMEDAvalon CL Fetal & Maternal Pod FDA UDI
- Description
- The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074. FDA UDI
Identifiers
- Catalog Number
- 866488 FDA UDI
- Primary DI / UDI-DI
- 00884838068179 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838068179 EUDAMED
- FDA Product Code
- HFM FDA UDI
- EMDN Code
- Z1208010499 CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Tocodynamometer probe FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2720 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 CL Fetal & Maternal Pod by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00884838068179 | 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 37e6ac65-e377-40d9-9fe7-7ba1d7708edd 61 fields · synced May 30, 2026
- FDA UDI 7fbb5a25-9839-47f2-ac7d-1ed35a354583 36 fields · synced May 30, 2026