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Sterile Single Use Absorbable Polydioxanone Suture with Needle - EUDAMED Registration 08800047830699

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 08800047830699 and manufactured by J world Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (J Double Heart), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium 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.

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EUDAMED Official Data
Class III
08800047830699
No
Sterile Single Use Absorbable Polydioxanone Suture with Needle
Trade Name: J Double Heart
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Device Description (EMDN)

MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (โ€˜BARBEDโ€™)

Device Classification
Risk Class
Class III
CND Nomenclatures Code
H010101010104
Trade Name
J Double Heart
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800047830699
Basic UDI
B-08800047830699
Version Date
March 06, 2025
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
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 - Regierungsprรคsidium 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