Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007335051

FEI Number

3007335051

Entity Name

TURON MEDTECH AB

City/State/Country

Varberg Halland, SE

Establishment Address

Kardanvagen 21, Varberg Halland 43232, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Turon MedTech AB (Owner Number: 10027316)

Owner / Operator Contact Address

Kardanvagen 21, Varberg, SE-N 43232, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

040503 gauge 18 stainless steel 040307 gauge 14 single use sterile 040501 gauge 14 stainless steel 040312 gauge 12 single use sterile 040301 gauge 18 single use sterile 042010 Standard needle holder 042503 Holder set Brevera 042501 Vertical Holder Brevera 042502 Lateral holder Brevera 042260 Horizontal Holder M 042285 Horizontal Holder M 8 GA 042150 Vertical Holder M 042170 Vertical Holder M 8 GA 042240 Vertical Holder E 042275 Horizontal Holder E 042295 Lateral Holder Eviva 042340 Vertical Holder Revolve 042330 Vertical Holder Eviva 042350 Horizontal Holder Atec 042335 Horizontal Holder Revolve 040504 gauge 20 stainless steel 040302 gauge 20 single use sterile 040502 gauge 16 stainless steel 040509 gauge 12 stainless steel 040309 GA20 open single use sterile 040308 gauge 16 single use sterile 040508 gauge 13 stainless steel 040505 GA20 open stainless steel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-12-17
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-10-23

Official Correspondent

Goran Ekstrom

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Turon MedTech AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007335051. Last updated year: 2026. Please use registration number 3007335051 when referencing this establishment in official correspondence.