Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033492726

FEI Number

3033492726

Entity Name

K Line Portugal Unipessoal Ltd

City/State/Country

Chaves Braga, PT

Establishment Address

Estrada de Braga, Lugar de S.Fausto, Armazem 4, Chaves Braga 5400-283, PT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

K LINE EUROPE GMBH (Owner Number: 10079939)

Owner / Operator Contact Address

Bonner Strasse 203-393, SEGRO Park Dusseldorf-Sud, Section 203 K, Dusseldorf-Benrath, DE-NW 40589, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K Clear CLEAR X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2021-01-05
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2022-04-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2026-05-08

Official Correspondent

Sherif Kandil

US Agent Details

Chris Brown Business: Aclivi, LLC Email: acliviconsulting@gmail.com Phone: (810) 3609773

Related Public Records

Same Entity

K LINE EUROPE GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044853366	K Line Egypt	Cairo, EG
3044462786	K Line Florida	West Palm Beach, FL, US
3035484470	Border Assembly S. de R.L de C.V.	Tijuana B.C. Baja California, MX

Similar Registrations

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3042902614	MYT USA CORP	Chino, CA, US
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
3009955691	HANGZHOU DTC MEDICAL APPARATUS CO., LTD	Hangzhou Zhejiang, CN
8043622	RICHBOLT ENTERPRISES	SIALKOT Punjab, PK
3008352964	SHANGHAI DOCHEM INDUSTRIES CO., LTD.	SHANGHAI, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033492726. Last updated year: 2026. Please use registration number 3033492726 when referencing this establishment in official correspondence.