Identity
- Model / Reference
- SENDO SMART 2 EUDAMEDUB-522A-BU11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800225500630 EUDAMED
- Basic UDI-DI
- 4981046-UBA0630-AZ EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Ub-522a-Bu11 by A&D Company, Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4981046-UBA0630-AZ | 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 (1)
- EUDAMED 54e8519a-dc58-4f05-a3e5-a06ef3793634 61 fields · synced Jul 30, 2026