Identity
- Model / Reference
- UM-211 EUDAMEDUM-211A-EC61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060006582356 EUDAMEDD-UM-211AU EUDAMED
- Basic UDI-DI
- 4981046-UMA2356-HR EUDAMEDB-UM-211AU EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Um-211a-Ec61 by A&D Company, Limited — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4981046-UMA2356-HR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4981046-UMA2356-HR | Class IIa | Active |
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Manufacturer
- Manufacturer
- A&D Company, Limited
- EUDAMED SRN
- JP-MF-000002158
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f102c1a1-575e-4809-b32a-1ec55f927278 61 fields · synced Jul 18, 2026
- EUDAMED 7bfd5d89-8da6-46f7-83af-7ed49ff085f6 61 fields · synced May 18, 2026