Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010264076

FEI Number

3010264076

Entity Name

MI3 LIMITED

City/State/Country

Blackburn Lancashire, GB

Establishment Address

Shadsworth Business Park, Nuttalls Way, Blackburn Lancashire BB1 2QJ, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mi3 Limited (Owner Number: 10043850)

Owner / Operator Contact Address

Shadsworth Business Park, Nuttalls Way, Blackburn, GB-LAN BB1 2QJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasopharyngoscope (flexible or rigid)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-12-22
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-05-30
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-05-10
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2014-12-28
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-03-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-05-10
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2016-12-22

Official Correspondent

Markus Pehling

US Agent Details

Anja Fair Business: KARL STORZ ENDOSCOPY-AMERICA, INC. Email: anja.fair@karlstorz.com Phone: (346) 8168200

Related Public Records

Same Entity

Mi3 Limited

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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010264076. Last updated year: 2026. Please use registration number 3010264076 when referencing this establishment in official correspondence.