Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617655

FEI Number

3003779679

Entity Name

Dr. Mach GmbH & Co. KG

City/State/Country

Grafing Bavaria, DE

Establishment Address

Am Brucker Feld 4, Grafing Bavaria 85567, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dr. Mach GmbH & Co. KG (Owner Number: 9038263)

Owner / Operator Contact Address

Am Brucker Feld 4, --, Grafing, DE-BY 85567, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mach LED 150 Mach LED 6MC Mach LED 6MC DF Mach LED 3 Smart Mach LED 300 MC Mach LED 300 Mach LED 6MC DF KV Mach LED 3 Mach LED 300DF Mach LED 2 Smart Mach LED 8MC DF S KV Mach LED 6MC F KV Mach LED 300DF SC Spot Mach LED 300DF SC Mach LED 8MC F Mach LED 6MC F Mach LED 5SC Mach LED 2MC Mach LED 6MC F S Mach LED 2 Mach LED 8MC F S Mach LED 150FP Mach LED 6MC DF S Mach LED 3MC Mach LED 3SC Mach LED 6MC F S KV Mach LED 8MC DF S Mach LED 6MC DF S KV Mach LED 150F Mach LED 8MC DF Mach LED 2SC Hybrid Mach LED 8MC F S KV Mach LED 5 Mach LED 2SC Mach LED 5MC Mach LED 8MC Mach LED 5 Smart Mach LED 8MC F KV Mach LED 8MC DF KV Mach LED 130F AC2000 Mach LED 120F Mach LED 130 Dental Mach LED 130 Dental P Mach LED 120 Mach 130 YLED-1F Mach LED 110 Mach LED 115 Mach LED 115C Mach LED 130 Plus Mach LED 130F Mach LED 130

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2016-09-23
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	1999-06-17

Official Correspondent

Michael Suhre

US Agent Details

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

Related Public Records

Same Entity

Dr. Mach GmbH & Co. KG

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
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617655. Last updated year: 2026. Please use registration number 9617655 when referencing this establishment in official correspondence.