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Medisana
EUDAMEDClass IIa (EU MDR)
Ref Chapter I and III of Annex IX of the Regulation (EU) 2017/745Model TMB-2284-BRef TMB-2287-BK（BU A52）Model TMB-2287-BK
Identity
- Trade Name
- MEDISANA EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-2284-B EUDAMEDChapter I and III of Annex IX of the Regulation (EU) 2017/745 EUDAMEDTMB-2287-BK EUDAMEDTMB-2287-BK（BU A52） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825303230 EUDAMED06932825304152 EUDAMED
- Basic UDI-DI
- 69328253MDR05PY EUDAMED69328253MDR08Q6 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Medisana by Guangdong Transtek Medical Electronics 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 | 69328253MDR05PY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Transtek Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000010684
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8a63e098-60f0-4942-beef-7ac143040d78 61 fields · synced Jun 20, 2026
- EUDAMED 205ec6d9-7ad7-4f72-8f4d-3f0d7b551146 61 fields · synced May 17, 2026