Diamond Fibrelight Handle - EUDAMED Registration 05051977001915

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 05051977001915 and manufactured by Penlon Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Diamond Fibrelight Handle / Stubby), 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.

Free Database

EUDAMED Official Data

Class I

05051977001915

Yes

Diamond Fibrelight Handle

Trade Name: Diamond Fibrelight Handle / Stubby

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Description (EMDN)

LARYNGOSCOPES

Device Classification

Risk Class

Class I

CND Nomenclatures Code

Z12021003

Trade Name

Diamond Fibrelight Handle / Stubby

Implantable

Reusable

Measuring Function

Registration Information

Primary DI

05051977001915

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

techsupport@penlon.com

Authorized Representative

Name

Obelis s.a.

SRN

BE-AR-000000106

Country

Belgium

Address

53 Boulevard Général Wahis Brussels

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

Latvia

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

Animal Tissues