Identity
- Trade Name
- Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Model / Reference
- BBSMT01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809475370005 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiograph, professional, single-channel
Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR by Make A Way Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiograph, professional, single-channel.
- HFVi monitor — MDOLORIS MEDICAL SYSTEMS · Class II
- VitalScan ANS — MEDEIA INC · Class II
- Telemetry 3 Lead Patient Cable — SCOTTCARE CORPORATION, THE · Class II
- Kosmos ECG Patient Cable - US — EchoNous · Class II
- K1000 — AliveCor · Class II
- CAM — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
- Faros — Bittium Biosignals , Ltd. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Make A Way Co., Ltd.
Sources (1)
- FDA UDI 1d75df6f-da0c-4cc7-909e-b8f58330ec47 32 fields · synced May 29, 2026