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Implantation Instrument Set- INTL - EUDAMED Registration 00180668000243

Access comprehensive regulatory information for Implantation Instrument Set- INTL 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 00180668000243 and manufactured by Uromedica, Incorporated in United States.

This page provides complete registration details including trade name (Uromedica ACT/ProACT Implantation Instrument Set), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00180668000243
No
Implantation Instrument Set- INTL
Trade Name: Uromedica ACT/ProACT Implantation Instrument Set
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Device Description (EMDN)

SURGICAL INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L99
Trade Name
Uromedica ACT/ProACT Implantation Instrument Set
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00180668000243
Basic UDI
B-00180668000243
Version Date
May 13, 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 Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No