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NIBP Cuff
EUDAMEDClass I (EU MDR)
Ref NDS-0106P-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-0106P-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971449611321 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
Category: General-purpose multi-parameter bedside monitor
NIBP Cuff by Shenzhen Envisen Industry Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 7f5d5b25-5a07-4b58-9666-89418897f587 61 fields · synced Jul 11, 2026