Manufacturer

Penlon

United Kingdom (ex Northern Ireland)Legal entities : Penlon Limited

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Malta, Poland, Portugal, Romania, Slovakia, Spain

EU representative : Obelis s.a. (Belgium)

Website

6 categories, 37 models including 37 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Medical/medicinal gas pipeline systems and related accessories	Z120309	MRI Flowmeter, Oxygen, single tube, direct probe, nipple outlet93/42 Single Air Flowmeter with threaded outlet (9/16” UNF), and Mk4, 4-bar Air probe93/42 Single Air Flowmeter, tubing nipple and 3/8” BSP connector93/42 Single Air Flowmeter, tubing nipple and Mk4 4-bar Air probe93/42 Single O₂ Flowmeter with threaded outlet (9/16” UNF), Mk4 O₂ probe93/42 9 others Single O₂ Flowmeter, tubing nipple and 1/8” NPT Universal thread93/42 Single O₂ Flowmeter, tubing nipple and 3/8” BSP connector93/42 Single O₂ Flowmeter, tubing nipple and Mk4 O₂ probe93/42 Single O₂ Flowmeter, tubing nipple and right-angled probe93/42 Single O₂ Flowmeter, with threaded outlet (9/16” UNF) and 1/8” NPT connector93/42 Single O₂ Flowmeter, with threaded outlet (9/16” UNF) and 3/8” BSP connector93/42 Twin Air Flowmeters, tubing nipples and Mk4 4-bar Air probe93/42 Twin O₂ Flowmeters, tubing nipples and 3/8” BSP connector93/42 Twin O₂ Flowmeters, tubing nipples and Mk4 O₂ probe93/42	IIa 93/42	EUDAMED record Report an error
Anaesthesia devices	Z1203010101	Prima 320 Advance Anaesthetic Machine93/42 Prima 320 Anaesthetic Machine93/42 Prima 440 Anaesthetic Machine93/42 Prima 445 Anaesthetic Machine93/42 Prima 450 Anaesthetic Machine93/42 3 others Prima 451 MRI Anaesthetic Machine93/42 Prima 460 Anaesthesia Machine Prima 460 Anaesthetic Machine93/42 Prima 465 Anaesthesia Machine93/42	IIb 93/42	EUDAMED record Report an error
Anaesthesia systems - hardware accessories	Z1203010180	Sigma Delta MRI Vaporizer / Halothane93/42 Sigma Delta MRI Vaporizer / Isoflurane93/42 Sigma Delta MRI Vaporizer / Sevoflurane93/42 Sigma Delta Vaporizer / Halothane93/42 Sigma Delta Vaporizer / Isoflurane93/42 2 others Sigma Delta Vaporizer / Sevoflurane93/42 Sigma EVA Vaporizer / Desflurane93/42	IIb 93/42	EUDAMED record Report an error
Laryngoscopes	Z12021003	Diamond Fibrelight Case / Blade (Macintosh Size 1,2,3,4), Standard Handle3 refs Diamond Fibrelight Handle / Penlight3 refs Diamond Fibrelight McCoy (Mac style) Case / Laryngoscope Blade Size 23 refs Disposable Laryngoscope Handle/ Box of 20 Green System MRI F/L McCoy (Mac Style) Case / Laryngoscope Blade Size 33 refs	I MDR	EUDAMED record Report an error
Adult and paediatric/neonatal pulmonary ventilators	Z1203010504	AV-S Anaesthesia Ventilator93/42 AV-S MRI Anaesthesia Ventilator93/42	IIb 93/42	EUDAMED record Report an error
Video laryngoscopes	Z12021004	Diamond H / Video Laryngoscope, HDMI-Wi-Fi3 refs	I MDR	EUDAMED record Report an error

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