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Zora
EUDAMEDClass IIa (EU MDR)
Ref TMB-2275-KModel 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
- ZORA EUDAMED
- 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-2275-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932825304589 EUDAMED
- Basic UDI-DI
- 69328253MDR05PY EUDAMED
- Direct Marketing DI
- 06932825304589 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Zora 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 (1)
- EUDAMED ae8a5841-5ce9-4eb8-b451-6d57f4b8e6de 61 fields · synced Jun 18, 2026