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Density Reagent - EUDAMED Registration 06973094411370

Access comprehensive regulatory information for Density Reagent 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 06973094411370 and manufactured by Junocare Medical Devices Ltd in China.

This page provides complete registration details including trade name (Density Reagent), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06973094411370
No
Density Reagent
Trade Name: Density Reagent
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Device Description (EMDN)

CLINICAL CHEMISTRY REAGENTS - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
W01019099
Trade Name
Density Reagent
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06973094411370
Basic UDI
B-06973094411370
Version Date
September 18, 2023
Manufacturer Last Update
November 14, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
BLOCK 13, LIANDO U VALLEY BEIJING
Email
lijinli@amberdale.cn
Authorized Representative
SRN
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Greece
Market Available
Austria:None~None, Belgium:None~None, Denmark:None~None, France:None~None, Greece:None~None, Italy:None~None, Netherlands:None~None, Turkey:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No