BEUDAMED

EU Manufacturer Active

Penlon Limited

SRN: GB-MF-000025115 · Penlon, Barton Lane, OX14 3NB Abingdon

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Penlon, Barton Lane, OX14 3NB Abingdon
Email: [email protected]
Phone: +44 1235 547000
Website: https://www.penlon.com/

Regulatory Overview

Regulation

Eu Mdr 9

Eu Mdd 3

Classification

Eu Md Class 1 9

Eu Md Class 2b 3

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
MDD Annex II (excluding section 4)	GB20/965349	SGS Belgium NV			Oct 13, 2023

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
Crystal Metal Macintosh / Disposable Laryngoscope Blade Size 1, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Crystal Metal Macintosh / Disposable Laryngoscope Blade Size 2, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Crystal Metal Macintosh / Disposable Laryngoscope Blade Size 4, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Crystal Metal Miller / Disposable Laryngoscope Blade Size 00, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Crystal Metal Miller / Disposable Laryngoscope Blade Size 1, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Crystal Metal Miller / Disposable Laryngoscope Blade Size 3, Box of 20	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Handle / Penlight	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Handle / Standard	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Handle / Stubby	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 0	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 1	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 2	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 3	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 4	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Macintosh / Laryngoscope Blade Size 5	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight McCoy (Mac style) Case / Laryngoscope Blade Size 2	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight McCoy (Mac style) Case / Laryngoscope Blade Size 4	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight McCoy (Mac style) Case/ Laryngoscope Blade Size 3	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Miller / Laryngoscope Blade Size 0	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Miller / Laryngoscope Blade Size 00	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Miller / Laryngoscope Blade Size 1	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Miller / Laryngoscope Blade Size 2	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Miller / Laryngoscope Blade Size 3	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Seward / Laryngoscope Blade Size 1	EU MDR	Eu Md Class 1	On Market	0
Diamond Fibrelight Seward / Laryngoscope Blade Size 2	EU MDR	Eu Md Class 1	On Market	0
Diamond H / Video Laryngoscope, HDMI-Wi-Fi	EU MDR	Eu Md Class 1	On Market	0
Diamond S / Video Laryngoscope	EU MDR	Eu Md Class 1	On Market	0
Green System MRI Handle / Standard	EU MDR	Eu Md Class 1	On Market	0
M2 / Disposable Laryngoscope Blade, Macintosh	EU MDR	Eu Md Class 1	On Market	0
M3 / Disposable Laryngoscope Blade, Macintosh	EU MDR	Eu Md Class 1	On Market	0
M3D / Disposable Laryngoscope Blade, Macintosh	EU MDR	Eu Md Class 1	On Market	0
M4 / Disposable Laryngoscope Blade, Macintosh	EU MDR	Eu Md Class 1	On Market	0
Prima 320 Advance Anaesthetic Machine	EU MDD	Eu Md Class 2b	On Market	1
Prima 320 Anaesthetic Machine	EU MDD	Eu Md Class 2b	On Market	1
SC760 High Suction Controller / High, Direct probe	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller / High, Remote with 44 mm rail clamp	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller / High, Remote with ‘V’ plate	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller / High, with 1/8” NPT Universal thread	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller / Kit, Prima, High with Remote ‘V’ plate, vacuum hose & BS probe	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller MRI / Kit, High with forward facing mounting system and 2m hose	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller MRI / Kit, High with forward facing mounting system and 4m hose	EU MDR	Eu Md Class 1	On Market	0
SC760 High Suction Controller MRI / Kit, High, DIN with direct probe and 1m hose	EU MDR	Eu Md Class 1	On Market	0
SC760 Low Suction Controller / Low, Direct probe	EU MDR	Eu Md Class 1	On Market	0
SC760 Low Suction Controller / Low, Direct probe, DIN	EU MDR	Eu Md Class 1	Not EU	0
SC760 Low Suction Controller / Low, Remote with 44 mm rail clamp	EU MDR	Eu Md Class 1	On Market	0
SC760 Low Suction Controller / Low, Remote with ‘V’ plate	EU MDR	Eu Md Class 1	Not EU	0
SC760 Twin Suction Controller / High, Direct probe	EU MDR	Eu Md Class 1	On Market	0
Sigma EVA Vaporizer / Desflurane	EU MDD	Eu Md Class 2b	On Market	1

PRRC

Name

Mary Ryan

Country

🇬🇧 United Kingdom

Authorized Representative

Name

Obelis s.a.

Country

🇧🇪 Belgium

Importer #1

Name

Medcaptain Europe B.V.

Country

🇳🇱 Netherlands

Importer #2

Name

PROYECTOS HOSPITALARIOS INTERNACIONAL, S.A

Country

🇪🇸 Spain

Importer #3

Name

Duomed Belgium NV

Country

🇧🇪 Belgium

Importer #4

Name

VEROMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Country

🇵🇱 Poland

Notified Bodies

SGS Belgium NV

1 cert

Competent Authority

Name

Federal agency for Medicines and Health Products / / Health Products Division

Country

🇧🇪 Belgium

More about this competent authority →

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