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Dia-Body Pouch Insulin Pump Pouch - EUDAMED Registration 08994228089201

Access comprehensive regulatory information for Dia-Body Pouch Insulin Pump Pouch in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08994228089201 and manufactured by CV ANGRREK LIAR in Indonesia.

This page provides complete registration details including trade name (Kaio-Dia), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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 I
08994228089201
No
Dia-Body Pouch Insulin Pump Pouch
Trade Name: Kaio-Dia
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Device Description (EMDN)

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12040180
Trade Name
Kaio-Dia
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08994228089201
Basic UDI
8994228UP-BPB1A8
Active Status
No
Manufacturer
Manufacturer Name
CV ANGRREK LIAR
Country
Indonesia
Country Type
NON_EU
Address
Jomblang Barat 666, RT 09 RW 03 Semarang
Email
info@kaio-care.com
Authorized Representative
SRN
FR-AR-000037267
Country
France
Address
12 RUE BERTRAND LAGRAULET ST NICOLAS
Email
info@kaio-dia.eu
Telephone
+33780919741
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No