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EUDAMED registration 00817612020124No

IV Catheter Securement Device

Dale Medical Products, Inc.Class IEU EUDAMEDTrade name: Dale IV Securement Device
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
C010180
Trade name
Dale IV Securement Device
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00817612020124
Basic UDI
B-00817612020124
Version date
February 21, 2023
Manufacturer last update
January 17, 2022
Active status
No
Manufacturer
Manufacturer name
Dale Medical Products, Inc.
Country
United States
Country type
NON_EU
Address
40 Kenwood Circle 02038 Franklin
Email
r.gruneberg@dalemed.net
Authorized representative
Name
Medical Device Safety Service GmbH (MDSS)
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:2019-06-27~2024-02-09, Italy:2019-06-27~2024-02-09
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PERIPHERAL I.V. CATHETERS AND CANNULAS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES

About this record

Access comprehensive regulatory information for IV Catheter Securement Device 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 00817612020124 and manufactured by Dale Medical Products, Inc. in United States.

This page provides complete registration details including trade name (Dale IV Securement Device), 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.