EUDAMED registration 08800027704262Yes

Single Use Infusion Pump

Name: Single Use Infusion Pump — EUDAMED registration 08800027704262
Creator: S&S Med Co.,Ltd.
Keywords: Single Use Infusion Pump, 08800027704262, CareVis BoluS, Class IIb, S&S Med Co.,Ltd., EUDAMED registration

S&S Med Co.,Ltd.Class IIbEU EUDAMEDTrade name: CareVis BoluS

VerifiedEUDAMED · official EU database

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: 08800027704262
Basic UDI: B-08800027704262
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

Name: Certification Experts
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

Device description (EMDN)

ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS

About this record

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 08800027704262 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.