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Affiniti 30 Diagnostic Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 795218Ref 795180Ref 795121
Identity
- Trade Name
- Affiniti 30 Diagnostic Ultrasound System EUDAMEDAFFINITI 30 DIAMOND SELECT SYSTEM FDA UDIAFFINITI 30 ULTRASOUND SYSTEM FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Affiniti Series Diagnostic Ultrasound System EUDAMED
- Model / Reference
- 795218 EUDAMEDFDA UDI795180 EUDAMED795121 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838128118 EUDAMED00884838112988 EUDAMED00884838097742 EUDAMEDFDA UDI00884838097957 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM432ST EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN 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
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGermany 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
Affiniti 30 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 (6)
- EUDAMED 6f644377-9c8b-4d35-884a-64494b4549be 61 fields · synced Oct 6, 2026
- EUDAMED 5e98c387-b9ef-4abd-a183-c3a91c5a8b7f 61 fields · synced May 18, 2026
- FDA UDI 4e340cf1-4690-4aef-85ad-a31961eb0cfe 32 fields · synced May 30, 2026
- FDA UDI f963ba5b-a8a4-476d-becb-312888f08456 32 fields · synced May 30, 2026
- EUDAMED d7acaa85-2c4d-40c1-972c-5207858c916f 61 fields · synced Jul 10, 2026
- EUDAMED 88b72723-f38e-423e-bd31-34b190c8b066 61 fields · synced Aug 2, 2026