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NIBP Cuff
EUDAMEDFDA UDIClass I (EU MDR)
Ref GCF1202(989803177511)Model GCF1200(989803177481)
Identity
- Trade Name
- NIBP Cuff EUDAMEDChangke Connect FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP Cuff EUDAMED
- Model / Reference
- GCF1200(989803177481) EUDAMEDGCF1202(989803177511) EUDAMEDGCF1202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973874210063 EUDAMEDFDA UDI
- Basic UDI-DI
- 697387421000043M EUDAMED
- Direct Marketing DI
- 06973874210063 EUDAMED
- 510(k) Number
- K191253 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
MR Safe FDA UDI
NIBP Cuff by Shenzhen Changke Connect Electronics Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697387421000043M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Changke Connect Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014704
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 097c57f7-417c-458e-9e9f-70e6e95cdafc 61 fields · synced Jul 22, 2026
- FDA UDI 5e93f2d0-2241-45d5-948f-d987d5f4af5e 33 fields · synced May 30, 2026