Pure Global

Trocars - EUDAMED Registration 06937845503790

Access comprehensive regulatory information for Trocars 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 06937845503790 and manufactured by Guangzhou T.K Medical instrument Co., Ltd. in China.

This page provides complete registration details including trade name (TK), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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 IIa
06937845503790
No
Trocars
Trade Name: TK
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

TROCAR STANDARD, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
K01010101
Trade Name
TK
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06937845503790
Basic UDI
69378455TRO04901BT
Version Date
February 27, 2025
Manufacturer Last Update
July 28, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
A601, Guangzhou International Business Incubator, Guangzhou Science Park,510663, Guangzhou, China Guangzhou
Email
wjc@gtkmedical.com
Authorized Representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Mรผnster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2024-10-10~2029-10-09
Device Characteristics
Human Tissues
No
Animal Tissues
No