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Pink Petal™ - EUDAMED Registration 00840161310668

Access comprehensive regulatory information for Pink Petal™ 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 00840161310668 and manufactured by Zirc Dental Products Inc. in United States.

This page provides complete registration details including trade name (Pink Petal™ - Saliva Ejector Holder - 100 Count), 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
00840161310668
No
Pink Petal™
Trade Name: Pink Petal™ - Saliva Ejector Holder - 100 Count
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Device Description (EMDN)

SALIVA ASPIRATORS AND SALIVA ABSORBENTS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q019001
Trade Name
Pink Petal™ - Saliva Ejector Holder - 100 Count
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840161310668
Basic UDI
0840161300073D
Version Date
January 10, 2025
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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No