Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680506

FEI Number

3002939620

Entity Name

MAVIG GMBH

City/State/Country

MÜNCHEN Bavaria, DE

Establishment Address

STAHLGRUBERRING 5, MÜNCHEN Bavaria 81829, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAVIG GmbH (Owner Number: 9009516)

Owner / Operator Contact Address

Stahlgruberring 5, --, Munich, DE-BY 81829, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BR - X-Ray Protection for Eyes LE - Portegra2 Lamps LE - Portegra2 Lamps ST - X-Ray Protective Drapes UT - Lower Body X-Ray Protection STEA - Sterile Covers RP - X-Ray Protection for Patients RD - X-Ray Protective Clothing for Radiation Exposure (Dental) RP - X-Ray Protective Clothing for Radiation Exposure (Patient) RA - X-Ray Protective Clothing for Radiation Exposure (Operator) RA - X-Ray Protective Clothing for Radiation Exposure (Operator) RD - X-Ray Protection Clothing for Radiation Exposure (Dental) RP - X-Ray Protection Clothing for Radiation Exposure (Patient) WD - Mobile Shields

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2008-03-20
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2010-10-14
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2010-10-14
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	1994-02-07
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2016-03-11
IWT	Shield, Gonadal	Radiology	Class 1	892.6500	2008-03-20
IWO	Apron, Protective	Radiology	Class 1	892.6500	2008-03-20
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2008-03-20
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2008-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

Bill Titus Business: TI-BA Enterprises, Inc. Email: bill@ti-ba.com Phone: (585) 2471212

Related Public Records

Same Entity

MAVIG 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
9610903	PAUSCH Medical GmbH	ERLANGEN Bavaria, DE

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 9680506. Last updated year: 2026. Please use registration number 9680506 when referencing this establishment in official correspondence.