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DS-11a
EUDAMEDClass IIa (EU MDR)
Ref DS-B10-23DModel Non-Invasive Digital Blood Pressure MonitorRef DS-B10-16D
Identity
- Trade Name
- DS-11a EUDAMED
- Device Name
- DS-A10 EUDAMED
- Model / Reference
- Non-Invasive Digital Blood Pressure Monitor EUDAMEDDS-B10-23D EUDAMEDDS-B10-16D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931140012126 EUDAMED04931140012041 EUDAMED
- Basic UDI-DI
- 4931140DS-A10EV9F EUDAMED
- Direct Marketing DI
- 04931140012126 EUDAMED04931140012041 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
DS-11a by Nihon Seimitsu Sokki Co., Ltd. — 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 | 4931140DS-A10EV9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nihon Seimitsu Sokki Co., Ltd.
- EUDAMED SRN
- JP-MF-000018344
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 447167c2-e4ef-4d6f-a721-8f14d6011557 61 fields · synced Jul 9, 2026
- EUDAMED 04b0e1a4-9854-4fd0-bb69-f1b7678ffda1 61 fields · synced May 18, 2026