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EUDAMED registration D-HK-A067ANo

Disposable Vaginal Speculums

Changzhou Huankang Medical Device Co., Ltd.Class IEU EUDAMEDTrade name: Vaginal Speculum
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
U089006
Trade name
Vaginal Speculum
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
D-HK-A067A
Basic UDI
B-HK-A067A
Version date
April 07, 2023
Manufacturer last update
July 01, 2021
Active status
No
Manufacturer
Manufacturer name
Changzhou Huankang Medical Device Co., Ltd.
Country
China
Country type
NON_EU
Address
22 Changhe Road, Sanhekou, Zhenglu, Changzhou, Jiangsu,
Email
Paul.zhai@huankang.com
Authorized representative
Name
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7, Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Poland
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VAGINAL SPECULUM, SINGLE-USE

About this record

Access comprehensive regulatory information for Disposable Vaginal Speculums 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 D-HK-A067A and manufactured by Changzhou Huankang Medical Device Co., Ltd. in China.

This page provides complete registration details including trade name (Vaginal Speculum), 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.