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NIBP Cuff
EUDAMEDClass I (EU MDR)
Ref NDS-0606P-20Model NDS-1102P-20、NDS-0106P-20、NDS-0206P-20、NDS-0506P-20、NDS-0606P-20、NDS-0706P-20、NDS-0902P-20、NDS-1202P-20、NDS-1302P-20、NDS-1002P-20
Identity
- Trade Name
- NIBP Cuff EUDAMED
- Model / Reference
- NDS-1102P-20、NDS-0106P-20、NDS-0206P-20、NDS-0506P-20、NDS-0606P-20、NDS-0706P-20、NDS-0902P-20、NDS-1202P-20、NDS-1302P-20、NDS-1002P-20 EUDAMEDNDS-0606P-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971449611352 EUDAMED
- Basic UDI-DI
- 697144961NIBPDSRF EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Envisen Industry 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 | 697144961NIBPDSRF | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Envisen Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000010838
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 295706b2-eb35-48b7-9b74-f7f976846cdf 61 fields · synced Jun 11, 2026