Manufacturer

Keeler

United Kingdom (ex Northern Ireland)Legal entities : Keeler Ltd

Markets : Austria · Belgium · Bulgaria · Croatia · Cyprus · Czechia · Denmark · Estonia · Finland · France · Germany · Greece · Hungary · Iceland · Ireland · Italy · Latvia · Lithuania · Malta · Netherlands and 11 more countries

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 9 · class I, II · latest in 2015 · see on the FDA website

EU representative : Keeler Europe Distribution, S.L. (Spain)

Website regulatory@keeler.co.uk

11 categories, 76 models including 75 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
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Ophtalmology assessments and diagnosis instruments - hardware accessories	Z12120180	0.4MM TUBE X20M3 refs 12V PSU & DRAWER KIT3 refs 2.8V POCKET HANDLE3 refs 3.6V LITHIUM BATTERY3 refs 5 PROTECTIVE SHIELDS - REGULAR 27 others ALUMINIUM CARRYING CASE3 refs API WIRELESS HEADBAND SERVICE KIT3 refs CHARGER / PSU TRANSFORMER+ LEAD3 refs CHARTS-FBO-PAD OF 50 CHIN REST PAPERS D-KAT Z-TYPE MOUNT3 refs DIELECTRIC PROJECTION MIRROR KIT3 refs DOUBLE CHARGER WALL MOUNT KIT3 refs DOUBLE CORD HANDLE POWER SUPPLY3 refs DSL DIGITAL LED REFRACTION STAND ACCESSORY KIT3 refs DSL DIGITAL TABLE ACCESSORY KIT3 refs DUST COVER2 refs DYNAMIC TARGETS FOR RETINOSCOPE EYE CAPS (2)3 refs HEADBAND & HINGE FOR LOUPES KEELER LENS CLOTH KEELER SILVER PENLIGHTS - PACK OF 63 refs LARGE THIMBLE COMPLETE FBO2 refs LIO ACCESSORY KIT LOUPE FLIP LEVER (PACK OF 7) Nose bridge PACK OF 5 COMFORT PADS PULSAIR CALIBRATION SYSTEM2 refs RETINOSCOPE BROW REST (LONG)2 refs SLIMLINE HANDLE SLEEVE - BLACK3 refs VANTAGE PLUS HIMAG VANTAGE+ DIGITAL FOOTSWITCH	I MDR	EUDAMED record Report an error
Tonometers	Z12120122	D-KAT (R-TYPE)93/42 D-KAT (R-TYPE) WITH CERTIFICATE93/42 D-KAT (T-TYPE)93/42 D-KAT (T-TYPE) WITH CERTIFICATE93/42 D-KAT R-TYPE (DISPOSABLE PRISM)93/42 18 others D-KAT T-TYPE (DISPOSABLE PRISM)93/42 D-KAT T-TYPE ASSY WITHOUT PRISM93/42 D-KAT Z-Type93/42 D-KAT Z-Type Tonometer (Disposable prism)93/42 KAT Z-TYPE EXCLUDING Z-TYPE POST93/42 KAT Z-TYPE INCLUDING Z-TYPE POST93/42 KEELER APPLANATION TONOMETER (R-TYPE)93/42 KEELER APPLANATION TONOMETER (T-TYPE)93/42 Pulsair Desktop93/42 Pulsair Intellipuff93/42 R-TYPE - DAT500R93/42 SLIMLINE KEELER APPLANATION TONOMETER (R-TYPE)93/42 SLIMLINE KEELER APPLANATION TONOMETER (T-TYPE)93/42 T-TYPE - DAT500T93/42 TOMEY APPLANATION TONOMETER (R-TYPE)93/42 TOMEY APPLANATION TONOMETER (T-TYPE)93/42 Z-KAT - DAT500Z93/42 TonoCare93/42 (no longer marketed)	I, IIa 93/42	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - other	Z12120199	2.8V LED STREAK RET & PROF SINGLE3 refs 3m Test Card - Letters, 60/6 -6/6 OAT3 refs 514/810nm LIO93/42 532nm LIO93/42 577nm LIO93/42 4 others AMSLER TEXT ONLY GERMAN3 refs ARC 514/810nm93/42 ARC 532nm93/42 TONOCLEAR93/42	I, IIb MDR, 93/42	EUDAMED record Report an error
Cryosurgery equipment	Z120102	CRYOMATIC MKII CONSOLE93/42 SINGLE USE RETINAL CRYO PROBE (BOX OF 10 PROBES)93/42	IIa, IIb 93/42	EUDAMED record Report an error
Ophthalmoscopes	Z12120114	2.8V LED PROFESSIONAL OPHTHALMOSCOPE3 refs API 2 CORDED KIT3 refs	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	KSL-H 5XC LED DiR Ref (White)3 refs PSL 500 PORTABLE SLIT LAMP3 refs	I MDR	EUDAMED record Report an error
Therapeutic and surgical ophtholmological treatments instruments - hardware accessories	Z12120280	DORC CRYOSTAR SINGLE USE PROBE ADAPTOR93/42 ERBE ERBOKRYO SINGLE USE PROBE ADAPTOR93/42	I 93/42	EUDAMED record Report an error
Direct outpatient otoscopes	Z12149006	2.8V POCKET OTO IN CASE3 refs	I MDR	EUDAMED record Report an error
Mobile scialytic lamps	Z12010702	K-LED & DOUBLE CHARGER & 2 BATTERIES, CLIP-ON3 refs	I MDR	EUDAMED record Report an error
Retinoscopes	Z12120118	2.8V PROFESSIONAL SPOT RETINOSCOPE IN CASE3 refs	I MDR	EUDAMED record Report an error
Various ENT instruments - hardware accessories	Z12149080	"DISPOSABLE SPECULA 6X 3.5MM/6X 5.5MM (PK OF 12)"3 refs	I MDR	EUDAMED record Report an error

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