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Disposable Surgical Kits - EUDAMED Registration 06973866555080

Access comprehensive regulatory information for Disposable Surgical Kits in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06973866555080 and manufactured by Xianning Full Guard Medical Products Co.,Ltd. in China.

This page provides complete registration details including trade name (Universal Kits), manufacturer information, authorized representative details, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), 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 IIa
06973866555080
No
Disposable Surgical Kits
Trade Name: Universal Kits
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Device Description (EMDN)

SURGICAL DRAPES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
T020199
Trade Name
Universal Kits
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06973866555080
Basic UDI
697386655FGSSBUN
Version Date
March 06, 2025
Manufacturer Last Update
September 18, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Yongan East Road Wenquan Economic Development Zone Xianning City
Email
dolly.zhou@fullguard-medical.com
Authorized Representative
SRN
ES-AR-000002008
Country
Spain
Address
141 Pso. Castellana Madrid
Email
legal@zoustech.eu
Regulatory Information
Competent Authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No