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Sparq Diagnostic Ultrasound Circular Edition - EUDAMED Registration 00884838097971

Access comprehensive regulatory information for Sparq Diagnostic Ultrasound Circular Edition in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00884838097971 and manufactured by Philips Ultrasound LLC in United States.

This page provides complete registration details including trade name (Sparq Diagnostic Ultrasound System), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIa
00884838097971
Yes
Sparq Diagnostic Ultrasound Circular Edition
Trade Name: Sparq Diagnostic Ultrasound System
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Device Description (EMDN)

INTERNAL ULTRASOUND SCANNERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z11040101
Trade Name
Sparq Diagnostic Ultrasound System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00884838097971
Basic UDI
0884838BM689U2
Version Date
September 04, 2024
Manufacturer Last Update
May 21, 2024
Active Status
Yes
Manufacturer
Manufacturer Name
Philips Ultrasound LLC
Country
United States
Country Type
NON_EU
Address
22100 Bothell Everett Highway Bothell
Email
eudamed@philips.com
Authorized Representative
SRN
NL-AR-000001422
Country
Netherlands
Address
6 Veenpluis Best
Email
EU.Auth.Rep@philips.com
Telephone
n/a
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Netherlands:2024-09-04~2099-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No