Welch Allyn, Inc.
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Welch Allyn Connex Integrated Wall System EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- VITAL SIGNS MONITOR WALL SYSTEM EUDAMEDWelch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and PanOptic Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Radio Ready; 100-240 V, 50-60 Hz AC, IEC Plug Type-B FDA UDI
- Model / Reference
- 901028 EUDAMEDFDA UDI84MTVEP-B EUDAMED
- Description
- Welch Allyn Connex Integrated Wall System with Masimo SpO2, SureTemp Plus Thermometry, Braun ThermoScan PRO 4000 Thermometry, BP Cuff and Cord Management System, Integrated MacroView Otoscope and PanOptic Ophthalmoscope, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Radio Ready; 100-240 V, 50-60 Hz AC, IEC Plug Type-B FDA UDI
Identifiers
- Catalog Number
- 84MTVEP-B FDA UDI
- Primary DI / UDI-DI
- 00732094119442 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00732094119442 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Multiple vital physiological parameter monitoring system, clinical
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (2)
- FDA UDI 5289e0a9-fec3-4d75-9060-0bd390d6afee 35 fields · synced Oct 7, 2026
- EUDAMED c3ab697a-574d-4b81-9210-9ba69fc502f8 61 fields · synced Sep 30, 2026