Avalon Toco MP Transducer
2 catalogue numbers from Avalon Toco MP Transducer, listed by Philips Medizin Systeme Böblingen GmbH, Germany, under Monitor, Uterine Contraction, External (For Use In Clinic). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
|---|---|
| FDA product code | HFM |
| Device type | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Record published | 2016-10-03 |
| Record revised | 2026-04-02 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH |
| Distribution end date | 2024-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Avalon Toco MP Transducer | In distribution | |
| Avalon TOCO MP Transducer | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Featherlite Toco | Parker Hannifin Corp. | 8 |
| Featherlite Toco Plus | Parker Hannifin Corp. | 4 |
| AIV | American IV Products, Inc. | 3 |
| Featherlite Aqua | Parker Hannifin Corp. | 2 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | Wipro GE Healthcare Private Ltd. | 2 |
| Koala Toco® | Clinical Innovations, LLC | 1 |
| Toco Transducer | Wipro GE Healthcare Private Ltd. | 1 |
| Avalon CL Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Fetal & Maternal Patch | Philips Medical Systems Hsg | 1 |
| Avalon CL Fetal & Maternal Pod | Philips Medizin Systeme Böblingen GmbH | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P890063 | 1990-09-12 | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.