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12cm ProACT Single- INTL - EUDAMED Registration 00180668000359

Access comprehensive regulatory information for 12cm ProACT Single- INTL in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00180668000359 and manufactured by Uromedica, Incorporated in United States.

This page provides complete registration details including trade name (12cm ProACT Single- INTL), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé), 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 IIb
00180668000359
No
12cm ProACT Single- INTL
Trade Name: 12cm ProACT Single- INTL
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Device Description (EMDN)

URINARY INCONTINENCE PROSTHESES - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P080199
Trade Name
12cm ProACT Single- INTL
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00180668000359
Basic UDI
B-00180668000359
Version Date
May 14, 2024
Manufacturer Last Update
June 16, 2023
Active Status
No
Manufacturer
Manufacturer Name
Uromedica, Incorporated
Country
United States
Country Type
NON_EU
Address
1840 Berkshire Lane N Plymouth
Email
info@uromedica-inc.com
Authorized Representative
SRN
FR-AR-000000182
Country
France
Address
11 RUE EMILE ZOLA BP 2332 GRENOBLE cedex 2
Email
info@medimark-europe.com
Telephone
+33 4 76 86 43 22
Regulatory Information
Competent Authority
Agence Nationale de Sécurité du Médicament et des Produits de Santé
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Market Available
Austria:2002-01-01~None, Belgium:2002-01-01~None, Bulgaria:2002-01-01~None, Croatia:2002-01-01~None, Cyprus:2002-01-01~None, Czechia:2002-01-01~None, Denmark:2002-01-01~None, Estonia:2002-01-01~None, Finland:2002-01-01~None, France:2002-01-01~None, Germany:2002-01-01~None, Greece:2002-01-01~None, Hungary:2002-01-01~None, Iceland:2002-01-01~None, Ireland:2002-01-01~None, Italy:2002-01-01~None, Latvia:2002-01-01~None, Liechtenstein:2002-01-01~None, Lithuania:2002-01-01~None, Luxembourg:2002-01-01~None, Malta:2002-01-01~None, Netherlands:2002-01-01~None, Norway:2002-01-01~None, Poland:2002-01-01~None, Portugal:2002-01-01~None, Romania:2002-01-01~None, Slovakia:2002-01-01~None, Slovenia:2002-01-01~None, Spain:2002-01-01~None, Sweden:2002-01-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No