EUDAMED registration 05051977001892Yes

Diamond Fibrelight Handle

Name: Diamond Fibrelight Handle — EUDAMED registration 05051977001892
Creator: Penlon Limited
Keywords: Diamond Fibrelight Handle, 05051977001892, Diamond Fibrelight Handle / Standard, Class I, Penlon Limited, EUDAMED registration

Penlon LimitedClass IEU EUDAMEDTrade name: Diamond Fibrelight Handle / Standard

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class I
CND nomenclatures code: Z12021003
Trade name: Diamond Fibrelight Handle / Standard
Implantable: No
Reusable: No
Measuring function: No

Registration information

Primary DI: 05051977001892
Basic UDI: 5051977LAR-RUHLYF
Active status: Yes

Manufacturer

Manufacturer name: Penlon Limited
Country: United Kingdom (ex Northern Ireland)
Country type: NON_EU
Address: Penlon, Barton Lane Abingdon
Email: techsupport@penlon.com

Authorized representative

Name: Obelis s.a.
SRN: BE-AR-000000106
Country: Belgium
Address: 53 Boulevard Général Wahis Brussels
Email: regulatory@obelis.net
Telephone: +32(2)73 25 954

Regulatory information

Competent authority: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable legislation: MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market: Poland
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

Device description (EMDN)

LARYNGOSCOPES

About this record

Access comprehensive regulatory information for Diamond Fibrelight Handle in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 05051977001892 and manufactured by Penlon Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Diamond Fibrelight Handle / Standard), manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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.