Disposable child blood cuff(CM1502)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- NIBP Cuff EUDAMEDDisposable child blood cuff(CM1502) FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP Accessory EUDAMED
- Model / Reference
- CM1103 EUDAMEDCM1502(115-054842-00) EUDAMED115-054842-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415903961 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB0100000232 EUDAMED
- 510(k) Number
- K182821 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Blood pressure cuff, reusable
Disposable child blood cuff(CM1502) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K182821 also covers:
- Fukuda Vital Signs Monitor — FUKUDA DENSHI USA, INC.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable SpO2 Sensor — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable infant blood cuff (CM1501) — Shenzhen Mindray Bio-Medical Electronics Co.
- Disposable large adult blood cuff(CM1504) — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (2)
- FDA UDI 59abbf59-5db5-4eb5-abbf-3e72eabfb7ca 34 fields · synced Jun 19, 2026
- EUDAMED bd60c891-de4f-4618-8eb4-1cf5e06945cf 61 fields · synced Jun 19, 2026