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Disposable Safety Lancets - EUDAMED Registration 16945630133029

Access comprehensive regulatory information for Disposable Safety Lancets 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 16945630133029 and manufactured by Sterilance Medical (Suzhou) Inc. in China.

This page provides complete registration details including trade name (STERiLANCE), 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
16945630133029
No
Disposable Safety Lancets
Trade Name: STERiLANCE
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Device Description (EMDN)

LANCETS WITH SAFETY SYSTEMS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V010401
Trade Name
STERiLANCE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
16945630133029
Basic UDI
6945630105BH
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
168 Putuoshan Suzhou
Email
smc@sterilance.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Bulgaria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No