EUDAMED registration 16095672021218No

Breath Sampling Vial

Name: Breath Sampling Vial — EUDAMED registration 16095672021218
Creator: Zhejiang ALWSCI Technologies Co., Ltd.
Keywords: Breath Sampling Vial, 16095672021218, Breath Sampling Vial, Class A, Zhejiang ALWSCI Technologies Co., Ltd., EUDAMED registration

Zhejiang ALWSCI Technologies Co., Ltd.Class AEU EUDAMEDTrade name: Breath Sampling Vial

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class A
CND nomenclatures code: W0503010101
Trade name: Breath Sampling Vial
Implantable: No
Reusable: No
Measuring function: No

Registration information

Primary DI: 16095672021218
Basic UDI: 697583867ALWCI12NCEQL
Version date: November 18, 2022
Manufacturer last update: November 14, 2022
Active status: No

Manufacturer

Manufacturer name: Zhejiang ALWSCI Technologies Co., Ltd.
Country: China
Country type: NON_EU
Address: No. 11 Fanrong Road Shaoxing
Email: marketing@alwsci.com

Authorized representative

Name: Kingsmead Service B.V.
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

Device description (EMDN)

SAMPLES ANALYSES, GLASS TUBES

About this record

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 16095672021218 and manufactured by Zhejiang ALWSCI Technologies Co., Ltd. in China.

This page provides complete registration details including trade name (Breath Sampling Vial), 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.