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Breath Sampling Vial - EUDAMED Registration 16095672020129

Access comprehensive regulatory information for Breath Sampling Vial in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 16095672020129 and manufactured by Zhejiang ALWSCI Technologies Co., Ltd. in China.

This page provides complete registration details including trade name (Breath Sampling Via), 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 A
16095672020129
No
Breath Sampling Vial
Trade Name: Breath Sampling Via
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Device Description (EMDN)

SAMPLES ANALYSES, GLASS TUBES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0503010101
Trade Name
Breath Sampling Via
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
16095672020129
Basic UDI
697583867ALWCI12CNEPW
Version Date
November 18, 2022
Manufacturer Last Update
November 14, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 11 Fanrong Road Shaoxing
Email
marketing@alwsci.com
Authorized Representative
SRN
NL-AR-000002066
Country
Netherlands
Address
36 Zonnehof Nootdorp
Email
office@kingsmead-service.com
Telephone
+31(0) 64 6571 005
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Market Available
Italy:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No