Pure Global

SMS isolation gown - EUDAMED Registration 06974618410084

Access comprehensive regulatory information for SMS isolation gown 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 06974618410084 and manufactured by Ningbo Transo-Medical Co., Ltd. in China.

This page provides complete registration details including trade name (Protective gowns,), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
06974618410084
No
SMS isolation gown
Trade Name: Protective gowns,
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T0205
Trade Name
Protective gowns,
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974618410084
Basic UDI
697461841TM0304JA
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 1608, No.18 Diamond Commercial plaza, No.409 Jiang'an Road Ningbo
Email
info@transo-medical.com
Authorized Representative
SRN
DE-AR-000005946
Country
Germany
Address
71 Niederrheinstraße Düsseldorf
Email
info@caretechion.de
Telephone
+49 211 2398900
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Denmark
Device Characteristics
Human Tissues
No
Animal Tissues
No