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T-piece Resuscitator, infant - EUDAMED Registration D-CT-11500WT

Access comprehensive regulatory information for T-piece Resuscitator, infant 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 D-CT-11500WT and manufactured by Besmed Health Business Corp. in Taiwan.

This page provides complete registration details including trade name (T-PIECE RESUSCITATOR SET), 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 IIa
D-CT-11500WT
No
T-piece Resuscitator, infant
Trade Name: T-PIECE RESUSCITATOR SET
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Device Description (EMDN)

MANUALLY OPERATED PULMONARY RESUSCITATORS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
R03020201
Trade Name
T-PIECE RESUSCITATOR SET
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-CT-11500WT
Basic UDI
B-CT-11500WT
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
5 Lane 116, Wu-Kong 2nd Rd, Wu-Ku District New Taipei City
Email
info@besmed.com
Authorized Representative
SRN
NL-AR-000037688
Country
Netherlands
Address
2b Lange Viestraat Utrecht
Email
eurep@casusconsulting.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Netherlands
Market Available
France:2004-10-05~2012-05-23, Netherlands:2008-03-03~2015-06-19
Device Characteristics
Human Tissues
No
Animal Tissues
No