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Skin Marking Grid - EUDAMED Registration 05016007205497

Access comprehensive regulatory information for Skin Marking Grid 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 05016007205497 and manufactured by Allergan Sales, LLC in United States.

This page provides complete registration details including trade name (Skin Marking Grid), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
05016007205497
No
Skin Marking Grid
Trade Name: Skin Marking Grid
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Device Description (EMDN)

SKIN MARKING DERMOGRAPHIC PENCILS AND PENS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V9004
Trade Name
Skin Marking Grid
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05016007205497
Basic UDI
0840228300014B
Version Date
March 05, 2025
Manufacturer Last Update
November 21, 2024
Active Status
No
Manufacturer
Manufacturer Name
Allergan Sales, LLC
Country
United States
Country Type
NON_EU
Address
2525 Dupont Drive Irvine, California
Email
customerservice@abbvie.com
Authorized Representative
SRN
IE-AR-000000650
Country
Ireland
Address
Clonshaugh Business & Technology Park Dublin 17
Email
EU_AR@abbvie.com
Telephone
+353 1 435 7700
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Market Available
United Kingdom (Northern Ireland only):2020-01-01~None, Türkiye:2020-01-01~None, Slovakia:2020-01-01~None, Slovenia:2020-01-01~None, Sweden:2020-01-01~None, Romania:2020-01-01~None, Portugal:2020-01-01~None, Poland:2020-01-01~None, Norway:2020-01-01~None, Netherlands:2020-01-01~None, Malta:2020-01-01~None, Latvia:2020-01-01~None, Luxembourg:2020-01-01~None, Lithuania:2020-01-01~None, Liechtenstein:2020-01-01~None, Italy:2020-01-01~None, Iceland:2020-01-01~None, Ireland:2020-01-01~None, Hungary:2020-01-01~None, Croatia:2020-01-01~None, Greece:2020-01-01~None, France:2020-01-01~None, Finland:2020-01-01~None, Spain:2020-01-01~None, Estonia:2020-01-01~None, Denmark:2020-01-01~None, Germany:2020-01-01~None, Czechia:2020-01-01~None, Cyprus:2020-01-01~None, Bulgaria:2020-01-01~None, Belgium:2020-01-01~None, Austria:2020-01-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No