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Boots
EUDAMEDClass IIa (EU MDR)
Ref TMB-1581-ZYRef TMB-2283-KModel TMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283
Identity
- Trade Name
- Boots EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- TMB-1581-ZY EUDAMEDTMB-1491-SN, TMB-1491-DS, TMB-1491-S, TMB-2283-K, TMB- 2283 EUDAMEDTMB-2283-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825305869 EUDAMED06932825305876 EUDAMED
- Basic UDI-DI
- 69328253MDR04PW EUDAMED69328253TMB1491PE 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Boots 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 | 69328253MDR04PW | 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 d58abe3b-cee9-40f3-b94d-352c84243e37 61 fields · synced Oct 6, 2026
- EUDAMED 53277df5-b9db-4392-9c33-90825e91488d 61 fields · synced May 18, 2026