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QuickChange, 50 count pack - EUDAMED Registration 00861859000487

Access comprehensive regulatory information for QuickChange, 50 count pack in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00861859000487 and manufactured by UI Medical, LLC in United States.

This page provides complete registration details including trade name (35817), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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 I
00861859000487
No
QuickChange, 50 count pack
Trade Name: 35817
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Device Description (EMDN)

ABSORBENT UNDERPADS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T04010299
Trade Name
35817
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00861859000487
Basic UDI
B-00861859000487
Version Date
March 19, 2024
Manufacturer Last Update
September 18, 2023
Active Status
No
Manufacturer
Manufacturer Name
UI Medical, LLC
Country
United States
Country Type
NON_EU
Address
555 E Ocean Blvd Ste 400 California
Email
hhc@uimed.com
Authorized Representative
SRN
DE-AR-000004974
Country
Germany
Address
97 Alsstr. Mรถnchengladbach
Email
joe@europecert.eu
Telephone
+49 2161 990 88 31
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No