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Non–Invasive Blood Pressure Monitoring Instruments
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M21-A00-E4C-T00-R00 M22-A00-E4C-T00-R00 M23-A00-E4C-T00-R00Model Assy EM4 ModuleModel Shipping Carton EM4 (System)
Identity
- Trade Name
- Non–Invasive Blood Pressure Monitoring Instruments EUDAMEDSphygmoCor FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- SphygmoCor XCEL EUDAMEDPackaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others). CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL: • XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only]. • XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]. FDA UDI
- Model / Reference
- Assy EM4 Module EUDAMEDM21-A00-E4C-T00-R00 M22-A00-E4C-T00-R00 M23-A00-E4C-T00-R00 EUDAMEDShipping Carton EM4 (System) EUDAMEDXCEL FDA UDI
- Description
- Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others). CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL: • XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only]. • XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 19351315000048 EUDAMED19351315000031 EUDAMEDFDA UDI
- Basic UDI-DI
- B-19351315000048 EUDAMEDB-19351315000031 EUDAMED
- 510(k) Number
- K122129 FDA UDI
- FDA Product Code
- DSK FDA UDIDXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1110 FDA UDI870.1130 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Non–Invasive Blood Pressure Monitoring Instruments by ATCOR MEDICAL Pty Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-19351315000048 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AtCor Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000034116
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 38bc86b0-1975-4a8a-9e99-156d43bfa187 61 fields · synced Oct 7, 2026
- EUDAMED 602323a4-1b15-419a-9922-8b8a3b10579f 61 fields · synced May 18, 2026
- FDA UDI 1b7eaf99-cf02-426d-8833-6c9a77536c48 34 fields · synced May 30, 2026