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Medisana
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TMB-2276-BModel TMB-2266, TMB-2271, TMB-2271-B, TMB-2271-BK, TMB-2271-A, TMB-2284, TMB-2284-B, TMB-2284-T, TMB-2275, TMB-2275-B, TMB-2275-K, TMB-2272-ZY, TMB-2272-AZY, TMB-1775-ZY, TMB-2276, TMB-2276-B, TMB-2276-A
Identity
- Trade Name
- MEDISANA EUDAMEDBODY PIXEL FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-2266, TMB-2271, TMB-2271-B, TMB-2271-BK, TMB-2271-A, TMB-2284, TMB-2284-B, TMB-2284-T, TMB-2275, TMB-2275-B, TMB-2275-K, TMB-2272-ZY, TMB-2272-AZY, TMB-1775-ZY, TMB-2276, TMB-2276-B, TMB-2276-A EUDAMEDTMB-2276-B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932825304404 EUDAMED06932825304145 FDA UDI
- Basic UDI-DI
- 69328253MDR05PY EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Medisana by Guangdong Transtek Medical Electronics Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69328253MDR05PY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 568644d4-7caf-45e6-b27f-bfc2a9fc2dad 61 fields · synced Oct 6, 2026
- FDA UDI 1c82ed62-5db1-4e2f-8e85-d87d3ed5cb22 32 fields · synced May 30, 2026