Pure Global

Laryngeal Mask Devices - EUDAMED Registration 06941951010486

Access comprehensive regulatory information for Laryngeal Mask Devices in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06941951010486 and manufactured by Guangdong Ecan Medical Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIa
06941951010486
No
Laryngeal Mask Devices
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

LARYNGEAL MASKS, SINGLE-LUMEN

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
R01020101
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06941951010486
Basic UDI
697336256LMASK01WW
Version Date
September 27, 2023
Manufacturer Last Update
February 28, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 1, No.222 Xindu Road,Chengjiao Street, ConghuaDistrict Guangzhou City,Guangdong Province
Email
hanliuyuan@ecanmed.com
Authorized Representative
SRN
DE-AR-000007996
Country
Germany
Address
11 Koenigsberger Strasse Muenster Hessen
Email
contact@glgi.de
Telephone
004960714977513
Regulatory Information
Competent Authority
DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
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