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Nibp Cuff
EUDAMEDClass I (EU MDR)
Ref Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745Model C8711
Identity
- Trade Name
- NIBP CUFF EUDAMED
- Device Name
- NIBP CUFF EUDAMED
- Model / Reference
- C8711 EUDAMEDRule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971018116585 EUDAMED
- Basic UDI-DI
- 697101811cuffVN EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Nibp Cuff by Shenzhen Medke Technology Co., Ltd. — Class I — 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 | 697101811cuffVN | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Medke Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019638
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4e277cb6-8e5c-4414-9832-cecac6a0db76 61 fields · synced Jul 9, 2026