Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710457

FEI Number

3003058840

Entity Name

BLAZEJEWSKI MEDI-TECH GMBH

City/State/Country

SEXAU Baden-Wurttemberg, DE

Establishment Address

RHEINSTRASSE 1, SEXAU Baden-Wurttemberg 79350, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BLAZEJEWSKI MEDI-TECH GMBH (Owner Number: 9011402)

Owner / Operator Contact Address

RHEINSTRASSE 1, --, SEXAU, DE-BW 79350, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-01-18

Official Correspondent

Reinhold Blazejewski

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

BLAZEJEWSKI MEDI-TECH GMBH

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
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3014407293	POLYGON MEDICAL, INC.	Manalapan, NJ, US
3028536560	ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD	Hangzhou Zhejiang, CN
3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE
3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710457. Last updated year: 2026. Please use registration number 9710457 when referencing this establishment in official correspondence.