DC-65S Diagnostic Ultrasound System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- DC-65S Diagnostic Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- DC-65S EUDAMEDFDA UDIDC-60, DC-60 Pro, DC-60 Exp, DC-60S, DC-65, DC-65 Pro, DC-65 Exp, DC-65S, DC-65T, DC-61, DC-62, DC-63, DC-69, DC-69S, DC-69 Exp, DC-69 Pro, DC-69T, DC-66 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415925741 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB050100085V EUDAMED
- 510(k) Number
- K182636 FDA UDI
- FDA Product Code
- IYN FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose ultrasound imaging system
DC-65S Diagnostic Ultrasound System by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as General-purpose ultrasound imaging system.
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Cleared under the same submission
K182636 also covers:
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 c2b3207c-c472-45da-8933-50ca9a7342f4 33 fields · synced Oct 6, 2026
- EUDAMED ab8a99b7-b4bb-4c5e-8c2d-17565c8e73a4 61 fields · synced Oct 6, 2026