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EUDAMED registration 00850024232105No

Fecal Incontinence Insert

Minnesota Medical TechnologiesClass IIaEU EUDAMEDTrade name: Navina Fecal Incontinence Insert, Size Large, 30/Box
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
G99
Trade name
Navina Fecal Incontinence Insert, Size Large, 30/Box
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00850024232105
Basic UDI
08654530003101LG
Version date
March 05, 2025
Manufacturer last update
June 24, 2021
Active status
No
Manufacturer
Manufacturer name
Minnesota Medical Technologies
Country
United States
Country type
NON_EU
Address
2446 Henry Road NW Stewartville
Email
rmanglin@mnmedicaltechnologies.com
Authorized representative
Name
MPS Medical Product Service GmbH
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Sweden
Market available
Denmark:None~None, Finland:None~None, France:None~None, Germany:None~None, Ireland:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Portugal:None~None, Spain:None~None, Sweden:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

GASTROINTESTINAL DEVICES - OTHER

About this record

Access comprehensive regulatory information for Fecal Incontinence Insert in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00850024232105 and manufactured by Minnesota Medical Technologies in United States.

This page provides complete registration details including trade name (Navina Fecal Incontinence Insert, Size Large, 30/Box), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.