Identity
- Model / Reference
- UM-212BLE EUDAMEDUM-212LA-EC61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-UM-212BLETS EUDAMED05060006582035 EUDAMED
- Basic UDI-DI
- B-UM-212BLETS EUDAMED4981046-UMA2035-GP 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-212ble by A&D Company, Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-UM-212BLETS | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-UM-212BLETS | 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 eca67aa6-5079-4e36-876d-bfcd296a5b01 61 fields · synced Jul 24, 2026
- EUDAMED a11f92c2-e721-4bad-a398-3597019352b2 61 fields · synced May 18, 2026