Identity
- Trade Name
- COMEN FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Model / Reference
- C50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945429010046 FDA UDI
- FDA Product Code
- DSJ FDA UDIMHX FDA UDIDSI FDA UDIMLD FDA UDIDRT FDA UDIDXN FDA UDIDQA FDA UDICBQ FDA UDIDSK FDA UDIDPS FDA UDICBR FDA UDINHO FDA UDIDXG FDA UDINHP FDA UDIDSB FDA UDICCK FDA UDICBS FDA UDIOLW FDA UDIFLL FDA UDIGXY FDA UDICCL FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1100 FDA UDI870.1025 FDA UDI870.2300 FDA UDI870.1130 FDA UDI870.2700 FDA UDI868.1500 FDA UDI870.1110 FDA UDI870.2340 FDA UDI868.1700 FDA UDI870.1435 FDA UDI870.2770 FDA UDI868.1400 FDA UDI868.1620 FDA UDI882.1400 FDA UDI880.2910 FDA UDI882.1320 FDA UDI868.1720 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
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
Yes
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
Category: Multiple vital physiological parameter monitoring system, clinical
Comen by Shenzhen Comen Medical Instruments Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vital physiological parameter monitoring system, clinical.
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Nightingale Monitoring System — ZOE MEDICAL INCORPORATED · Class II
- Tempus Pro — Remote Diagnostic Technologies Limited · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Lutech — Lutech Industries · 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
- Shenzhen Comen Medical Instruments Co., LTD.
Sources (1)
- FDA UDI 840ee35e-7a59-4876-96f2-9bfa18f62f9f 32 fields · synced Jun 8, 2026