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Sterile Vaginal Speculums for Single Use - EUDAMED Registration 16950921000263

Access comprehensive regulatory information for Sterile Vaginal Speculums for Single Use 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 16950921000263 and manufactured by Taizhou Kangjian Medical Equipments Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktรผberwachung Medizinprodukte Bayern), 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
16950921000263
No
Sterile Vaginal Speculums for Single Use
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

VAGINAL SPECULUM, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
U089006
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
16950921000263
Basic UDI
69509210FZL3M
Version Date
December 07, 2024
Manufacturer Last Update
August 10, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
The Machine Electricity Zone, (Hang Ni Kan) Yuhuan County, Zhejiang Province
Email
webmaster@kangjiancn.com
Authorized Representative
SRN
DE-AR-000007996
Country
Germany
Address
11 Koenigsberger Strasse Muenster Hessen
Email
contact@phoenix-medtech.de
Telephone
004960714977513
Regulatory Information
Competent Authority
DE/CA304 - Marktรผberwachung Medizinprodukte Bayern
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No