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 SureTemp Plus Thermometry, BP Cuff and Cord Management System, Otoscope and Ophthalmo scope Heads Not Included, 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 FDA UDI
- Model / Reference
- 901028 EUDAMEDFDA UDI84XTVXX-B EUDAMED
- Description
- Welch Allyn Connex Integrated Wall System with SureTemp Plus Thermometry, BP Cuff and Cord Management System, Otoscope and Ophthalmo scope Heads Not Included, 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 FDA UDI
Identifiers
- Catalog Number
- 84XTVXX-B FDA UDI
- Primary DI / UDI-DI
- 00732094057027 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00732094057027 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
Yes
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 4fc578f9-b44a-4923-ae95-c8474e2a28ff 35 fields · synced Oct 8, 2026
- EUDAMED 64263a09-fd38-47f4-b1ab-c089f5e3a603 61 fields · synced Oct 8, 2026