Avalon CL Basestation
by Philips Medizin Systeme Böblingen GmbH Germany EUDAMEDGUDID
Ref 866074
Product code DRGEMDN Z1208010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00884838034228 | Date8 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00884838034228 | Date19 Oct 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Avalon CL Basestation EUDAMEDAvalon CL Base Station GUDID
- Generic Name
- Foetal/maternal prenatal monitoring system transceiver
- Device Name
- Fetal Basestation
- Model / Ref / Catalog
- 866074, Avalon CL Basestation
- Primary DI / UDI-DI
- 00884838034228
- Basic UDI-DI
- B-00884838034228
- FDA Product Code
- DRG
- EMDN Code
- Z1208010499 Cardiotocographic telemetry instruments - other
- GMDN Term
- Foetal/maternal prenatal monitoring system transceiver
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.2910
- Market of Registration
- Austria
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 866074 | Avalon CL Basestation |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000006026
Other devices from Philips Medizin Systeme Böblingen GmbH
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Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED cfc87531-9eda-42ac-aaac-af3b551074f0
- FDA UDI 94225874-c0e7-41ba-8c33-38eb57dae289