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Retainer Box and Denture Box - EUDAMED Registration 00840161304353

Access comprehensive regulatory information for Retainer Box and Denture Box 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 00840161304353 and manufactured by Zirc Dental Products Inc. in United States.

This page provides complete registration details including trade name (Retainer Box 1.5" Deep 12 pk Teal), manufacturer information, authorized representative details, competent authority (DE/CA21 - Bezirksregierung Köln Dezernat 24 ), 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 I
00840161304353
No
Retainer Box and Denture Box
Trade Name: Retainer Box 1.5" Deep 12 pk Teal
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Device Description (EMDN)

CLINICAL USE CONTAINERS (NON-IVD) - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V0499
Trade Name
Retainer Box 1.5" Deep 12 pk Teal
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840161304353
Basic UDI
0840161300153C
Version Date
December 14, 2023
Manufacturer Last Update
July 20, 2023
Active Status
No
Manufacturer
Manufacturer Name
Zirc Dental Products Inc.
Country
United States
Country Type
NON_EU
Address
3918 State Highway 55 S.E Buffalo
Email
zirc@zirc.com
Authorized Representative
SRN
DE-AR-000005612
Country
Germany
Address
1c Benzstrasse Leverkusen
Email
info.dental.eu@medicom.com
Telephone
+49(0)2171706670
Regulatory Information
Competent Authority
DE/CA21 - Bezirksregierung Köln Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No