Heel Incision
- Risk class
- Class IIa
- CND nomenclatures code
- V010401
- Trade name
- SteriHeel Baby
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 16945630135344
- Basic UDI
- 6945630130BG
- Active status
- No
- Manufacturer name
- Sterilance Medical (Suzhou) Inc.
- Country
- China
- Country type
- NON_EU
- Address
- 168 Putuoshan Suzhou
- smc@sterilance.com
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- United Kingdom (Northern Ireland only)
- 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
- Human tissues
- No
- Animal tissues
- No
LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
Access comprehensive regulatory information for Heel Incision 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 16945630135344 and manufactured by Sterilance Medical (Suzhou) Inc. in China.
This page provides complete registration details including trade name (SteriHeel Baby), 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.