Identity
- Trade Name
- Electronic Sphygmomanometer EUDAMED
- Device Name
- Electronic Sphygmomanometer EUDAMED
- Model / Reference
- WBP202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300394 EUDAMED
- Basic UDI-DI
- 69325623100123W EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Electronic Sphygmomanometer by Guangdong Biolight Meditech Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160349 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69325623100123W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED efc95ae1-1cb6-4e54-abaf-f293a0d2662f 61 fields · synced Jun 19, 2026
- FDA 510(k) K160349 1 fields · synced May 18, 2026