Pure Global

Dale ACE Connector with ENFit Connection - EUDAMED Registration 00817612020261

Access comprehensive regulatory information for Dale ACE Connector with ENFit Connection in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00817612020261 and manufactured by Dale Medical Products, Inc. in United States.

This page provides complete registration details including trade name (Dale ACE Connector), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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 IIa
00817612020261
No
Dale ACE Connector with ENFit Connection
Trade Name: Dale ACE Connector
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

GASTROINTESTINAL TUBES - ACCESSORIES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
G0280
Trade Name
Dale ACE Connector
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00817612020261
Basic UDI
B-00817612020261
Version Date
August 22, 2022
Manufacturer Last Update
January 17, 2022
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
40 Kenwood Circle 02038 Franklin
Email
r.gruneberg@dalemed.net
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~None, Italy:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No