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MEDICAL SUPPLY UNIT - EUDAMED Registration +GG462IHS00780CE

Access comprehensive regulatory information for MEDICAL SUPPLY UNIT 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 +GG462IHS00780CE and manufactured by Oxigenoterapia Norte SACIFIA in Argentina.

This page provides complete registration details including trade name (OXIGENOTERAPIA NORTE), manufacturer information, authorized representative details, competent authority (DE/CA24 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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 IIa
+GG462IHS00780CE
Yes
MEDICAL SUPPLY UNIT
Trade Name: OXIGENOTERAPIA NORTE
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Device Description (EMDN)

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V9099
Trade Name
OXIGENOTERAPIA NORTE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
+GG462IHS00780CE
Basic UDI
++G462MAS0257PM
Version Date
August 22, 2023
Manufacturer Last Update
April 20, 2023
Active Status
Yes
Manufacturer
Country
Argentina
Country Type
NON_EU
Address
1954 Coronel Bogado Castelar
Email
info@oxigenoterapia.com.ar
Authorized Representative
SRN
DE-AR-000007685
Country
Germany
Address
The Squaire 12, At the airport, Frankfurt
Email
miki.m@arazygroup.com
Telephone
+49 (0) 69 95932-5090
Regulatory Information
Competent Authority
DE/CA24 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No