Pure Global

NIBP Neonates - EUDAMED Registration 00840682108966

Access comprehensive regulatory information for NIBP Neonates 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 00840682108966 and manufactured by GE Medical Systems Information Technologies, Inc. in United States.

This page provides complete registration details including trade name (CLASSIC-CUF, NEONATAL3, 2 TB NEO-SNAP, 06 - 11 CM, SINGLE ), 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
Class I
00840682108966
No
NIBP Neonates
Trade Name: CLASSIC-CUF, NEONATAL3, 2 TB NEO-SNAP, 06 - 11 CM, SINGLE
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12040180
Trade Name
CLASSIC-CUF, NEONATAL3, 2 TB NEO-SNAP, 06 - 11 CM, SINGLE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840682108966
Basic UDI
8406821BUG00041GS
Version Date
February 07, 2025
Manufacturer Last Update
October 24, 2024
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
3114 N Grandview Blvd Waukesha
Email
CoE.Postmarket@ge.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
eudamed@gehealthcare.com
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No