Pure Global

ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 - EUDAMED Registration 00816784020680

Access comprehensive regulatory information for ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100 in the European Union medical device market through Pure Global AI's free database. This IVD Annex II List B device is registered with EU EUDAMED under Primary DI 00816784020680 and manufactured by LGC Clinical Diagnostics, Inc. in United States.

This page provides complete registration details including trade name (ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
IVD Annex II List B
00816784020680
No
ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
Trade Name: ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

BACTERIOLOGY CONTROLS - INF.IMM.

Device Classification
Risk Class
IVD Annex II List B
CND Nomenclatures Code
W0105080801
Trade Name
ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00816784020680
Basic UDI
B-00816784020680
Version Date
July 26, 2023
Manufacturer Last Update
July 24, 2023
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
37 Birch Street Milford
Email
alexander.potter@lgcgroup.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
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Ireland
Device Characteristics
Human Tissues
Yes
Animal Tissues
No