MINITUBE AB

FDA Device Registration & Listing · TRANGSVIKEN Jamtland, SE · Registration 8032009

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8032009
FEI Number
3001697252
Entity Name
MINITUBE AB
City/State/Country
TRANGSVIKEN Jamtland, SE
Establishment Address
Byvagen 44, TRANGSVIKEN Jamtland 835 96, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MINITUBE AB (Owner Number: 8032009)
Owner / Operator Contact Address
BYVAGEN 44, --, TRANGSVIKEN, SE-NOTA 835 96, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RINN® Tight Sensor Cover –Size 1 RINN® Large Digital Sensor Covers (Soft Overbag Cover) RINN® Tight Digital Sensor Cover –Size 1.5/2 RINN® Tight Digital Sensor Cover - Size 1 Barrier sleeves Dentasleeve Minitube X-Ray Sensor Sheath Intraoral Camera Sheath MEDLINE LUBRICATED THERMOMETER SHEATH Medline thermometer sleeves

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2016-06-28
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2021-08-09
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2011-09-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-09-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

MINITUBE AB
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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8032009. Last updated year: 2026. Please use registration number 8032009 when referencing this establishment in official correspondence.
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