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Affiniti 70 Diagnostic Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 795210
Identity
- Trade Name
- Affiniti 70 Diagnostic Ultrasound System EUDAMEDAffiniti 70 Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Affiniti Series Diagnostic Ultrasound System EUDAMEDVM12.0 FDA UDI
- Model / Reference
- 795210 EUDAMEDFDA UDI
- Description
- VM12.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838124998 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM432ST EUDAMED
- 510(k) Number
- K242020 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIOBJ FDA UDIQIH 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 UDI892.1560 FDA UDI892.1570 FDA UDI870.1200 FDA UDI892.2050 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Affiniti 70 Diagnostic Ultrasound System by Philips Ultrasound LLC — Class IIa — 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 | 0884838BM432ST | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED d60a00b9-7130-4a9f-99af-292258f3d63d 61 fields · synced Oct 6, 2026
- FDA UDI b6ec2290-2af2-4c92-8b23-fcfef77e600e 34 fields · synced May 30, 2026