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EUDAMED registration 06974445421147Yes

Shadowless Operating Lamp

Harbin Howell Medical Apparatus and Instruments Co., Ltd.Class IEU EUDAMEDTrade name: HOWELL
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12010701
Trade name
HOWELL
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
06974445421147
Basic UDI
697444542HE700/500JK
Version date
December 28, 2024
Manufacturer last update
June 17, 2022
Active status
Yes
Manufacturer
Manufacturer name
Harbin Howell Medical Apparatus and Instruments Co., Ltd.
Country
China
Country type
NON_EU
Address
No.134-1 Junmin Street,Xiangfang District Harbin City, Heilongjiang Province
Email
785911957@qq.com
Authorized representative
Name
Caretechion GmbH
SRN
DE-AR-000005946
Country
Germany
Address
71 Niederrheinstraße Düsseldorf
Email
info@caretechion.de
Telephone
+49 211 2398900
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

FIXED SCIALYTIC LAMPS

About this record

Access comprehensive regulatory information for Shadowless Operating Lamp 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 06974445421147 and manufactured by Harbin Howell Medical Apparatus and Instruments Co., Ltd. in China.

This page provides complete registration details including trade name (HOWELL), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf 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.