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NIBP Cuff
EUDAMEDFDA UDIClass I (EU MDR)
Ref CM1500C(001B-30-70679)Model CM1103
Identity
- Trade Name
- NIBP Cuff EUDAMEDCUFF,DSNEO,CM1500C,5.8-10.9(1) FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP Accessory EUDAMED
- Model / Reference
- CM1103 EUDAMEDCM1500C(001B-30-70679) EUDAMED001B-30-70679 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904028927 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB0100000232 EUDAMED
- 510(k) Number
- K143195 FDA UDI
- FDA Product Code
- MHX 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
- 870.1025 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
NIBP Cuff by Shenzhen Mindray Bio-Medical 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 | 69449040AB0100000232 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 333694c7-6e02-4208-bed7-53b07b352191 61 fields · synced Jun 19, 2026
- FDA UDI abe544e7-7f27-45c6-95e8-884b98cb9766 34 fields · synced May 22, 2026