Identity
- Trade Name
- COMEN FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Model / Reference
- C80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945429010053 FDA UDI
- FDA Product Code
- MLD FDA UDIMHX FDA UDIDSI FDA UDIDRT FDA UDIDSJ FDA UDINHP FDA UDIOLW FDA UDINHO FDA UDIGXY FDA UDIDXN FDA UDIDQA FDA UDICBR FDA UDICCK FDA UDICBQ FDA UDIDSK FDA UDICBS FDA UDIDPS FDA UDICCL FDA UDIDXG FDA UDIDSB FDA UDIFLL FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2300 FDA UDI870.1100 FDA UDI868.1500 FDA UDI882.1400 FDA UDI882.1320 FDA UDI870.1130 FDA UDI870.2700 FDA UDI868.1700 FDA UDI868.1400 FDA UDI870.1110 FDA UDI868.1620 FDA UDI870.2340 FDA UDI868.1720 FDA UDI870.1435 FDA UDI870.2770 FDA UDI880.2910 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
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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 |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
Sources (1)
- FDA UDI 01ccfbca-f066-415f-aede-b0b1b40a439e 32 fields · synced Jun 8, 2026