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Single Use Infusion Pump - EUDAMED Registration 08800027705306

Access comprehensive regulatory information for Single Use Infusion Pump in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08800027705306 and manufactured by S&S Med Co.,Ltd. in Republic of Korea.

This page provides complete registration details including trade name (CareVis BoluS), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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 IIb
08800027705306
Yes
Single Use Infusion Pump
Trade Name: CareVis BoluS
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Device Description (EMDN)

ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
A05010102
Trade Name
CareVis BoluS
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800027705306
Basic UDI
B-08800027705306
Version Date
January 07, 2022
Manufacturer Last Update
November 29, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
S&S Med Co.,Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
67 Bongseong-ro Gunpo-si, Gyeonggi-do
Email
suensumed@daum.net
Authorized Representative
SRN
NL-AR-000000235
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
e.unk@certification-experts.com
Telephone
+31850073210
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:2017-01-30~2100-01-01
Device Characteristics
Human Tissues
No
Animal Tissues
No