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EUDAMED registration 08800047817652No

Sterile Single Use Absorbable Polydioxanone Suture with Needle

J world Co., Ltd.Class IIIEU EUDAMEDTrade name: Countourel
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class III
CND nomenclatures code
H010101010104
Trade name
Countourel
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
08800047817652
Basic UDI
B-08800047817652
Version date
September 30, 2024
Manufacturer last update
August 22, 2024
Active status
No
Manufacturer
Manufacturer name
J world Co., Ltd.
Country
Republic of Korea
Country type
NON_EU
Address
79 Uiryodanji-gil Okcheon-eup, Okcheon-gun, Chungcheongbuk-do
Email
sc.eum@jwcosmetic.com
Authorized representative
Name
KTR Europe GmbH
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory information
Competent authority
DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Austria
Market available
Austria:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’)

About this record

Access comprehensive regulatory information for Sterile Single Use Absorbable Polydioxanone Suture with Needle in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 08800047817652 and manufactured by J world Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (Countourel), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.