Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006984716

FEI Number

3006984716

Entity Name

SCHOTT CR, S.R.O.

City/State/Country

Valasske Mezirici Zlinsky Kraj, CZ

Establishment Address

Zasovska 850, Valasske Mezirici Zlinsky Kraj 75071, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SCHOTT CR, s.r.o. (Owner Number: 10025265)

Owner / Operator Contact Address

Zasovska 850, Valasske Mezirici, CZ-72 75071, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fiber Optic Rod Fiber Optic Rod Fiber Optic Rod Light, Fiberoptic, Dental Light Guide Cable Fiber Optic Rod Light, Fiberoptic, Dental EyeMag Light II Prismatic Light Deflector Fiber Optic Rod

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-12-18
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-12-18
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-12-18
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2022-12-23
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2022-05-19
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-12-18
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2022-12-23
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2015-12-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-12-10
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-12-18

Official Correspondent

Joshua Beu

US Agent Details

Joshua Beu Business: SCHOTT North America Inc, - Lighting and Imaging Email: joshua.beu@us.schott.com Phone: (508) 9097409

Related Public Records

Same Entity

SCHOTT CR, s.r.o.

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
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006984716. Last updated year: 2026. Please use registration number 3006984716 when referencing this establishment in official correspondence.