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INSM1 (QR128) - EUDAMED Registration 04255597804845

Access comprehensive regulatory information for INSM1 (QR128) in the European Union medical device market through Pure Global AI's free database. This Class C device is registered with EU EUDAMED under Primary DI 04255597804845 and manufactured by biocyc Biotechnologie GmbH & Co. KG in Germany.

This page provides complete registration details including trade name (INSM1 (QR128)), manufacturer information, competent authority (DE/CA76 - Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Abt. Gesundheit - Dezernat G4 ), 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.

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EUDAMED Official Data
Class C
04255597804845
No
INSM1 (QR128)
Trade Name: INSM1 (QR128)
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Device Description (EMDN)

PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

Device Classification
Risk Class
Class C
CND Nomenclatures Code
W01030709
Trade Name
INSM1 (QR128)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04255597804845
Basic UDI
42555978ANTIBODYI0104E
Version Date
November 12, 2024
Manufacturer Last Update
January 04, 2024
Active Status
No
Manufacturer
Country
Germany
Country Type
EU_MEMBER_STATE
Address
4 Am Mühlenberg Potsdam
Email
info@biocyc.de
Regulatory Information
Competent Authority
DE/CA76 - Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Abt. Gesundheit - Dezernat G4
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
Yes
Animal Tissues
Yes