Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005301392

FEI Number

3005301392

Entity Name

FREY SPOLKA JAWNA

City/State/Country

PIASECZNO Mazowieckie, PL

Establishment Address

38 WOLODYJOWSKIEGO, PIASECZNO Mazowieckie 05502, PL

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FREY SPOLKA JAWNA (Owner Number: 9076361)

Owner / Operator Contact Address

38 WOLODYJOWSKIEGO, --, PIASECZNO, MAZOWIECKIE, PL-NOTA 05502, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SLI-200 4K SLI-200 SLI-200 4K PRO TN-100 AP-300 AP-250BY AP-600 AP-250 AP-50 AP-600L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2018-12-27
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2019-04-30
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2005-08-12

Official Correspondent

Wojciech Frey

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

FREY SPOLKA JAWNA

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K870750	Keeler Instruments, Inc.	KEELER PULSAIR NON CONTACT TONOMETER	1987-03-17

Similar Registrations

Registration Number	Establishment Name	Location
3017175640	PHELCOM TECHNOLOGIES	Sao Carlos Sao Paulo, BR
3029906968	OIVI AS	Oslo, NO
3010610157	CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD	Chongqing, CN
3006546174	FABRINET CO., LTD.	Klongluang Pathum Thani, TH
3020309552	CHONGQING SS MEDICAL EQUIPMENTS CO., LTD	Chongqing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005301392. Last updated year: 2026. Please use registration number 3005301392 when referencing this establishment in official correspondence.