Manufacturer

Heine

GermanyLegal entities : HEINE Optotechnik GmbH & Co. KG

Markets : Germany · United States

Approvals : EU – class I · United States (FDA) – 510(k) : 8 · class I, II · latest in 2015 · see on the FDA website

9 categories, 119 models including 119 on the market, 1 country

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
General medicine diagnosis and monitoring instruments - other	Z12040199	BETA 200 LED OPH./OTO.SET+BETA BETA OPH./OTO.SET+BETA2 refs BETA 200 LED OPHT./OT.KIT/4 NT BETA OPHT./OTO.KlT/4 NT2 refs BETA 200 LED OPHT./OT.SET/4 NT BETA OPHTJOT.SET/4 NT2 refs BETA 200 OPHT./OT.SET/4USB+TR. BETA OPHT./OT.SET/4USB+TR.2 refs BETA OPH./ST.-RET.LED SET/4 NT BETA OPH./SKlA.SET/4 NT2 refs 21 others BETA OPH/ST.RET LED SET/USB+TR2 refs BETA OPHTH./RETIN. LED SET C-145 BETA OPHTH./LED RETIN.SET2 refs BETA X OPT. STUDENT SET EN 200/BETA200 LED OTO.+OPHTH. EN200/BETA OTO+BETA OPH.2 refs EN 200/BETA200 OT./OPH.KIT/LED EN200/BETA OTO/OPH.KIT2 refs EN 200/K 180 OPHTH.+ OTOSC./LED EN 200/K180 OPHTH.+ OTO.KIT/LED HR2,5X340+LL2+I-VIEW A.S-FRAME HR2,5+LL2+1-VIEW AS-FRAME3 refs HRP3,5X/420+LL2+I-VIEW A.S-FR. HRP+LL2+1-VIEW A.S-FR.3 refs K180 LED OPH./OTO. SET+BETA K180 LED OPH./OTO. SET/4 USB+TR. KIT 10C:ML4+EN50+HRP6/3403 refs KIT 11C:ML4+I-VIEW+HR2,5/520 ML4+1-VIEW+HR3 refs KIT 12C:ML4+EN50+HR2,5/520 ML4+EN50 UPL.+HR3 refs KIT 1: ML4+I-V+S-G+HR2,5/340 ML4+1-V+S-G+HR3 refs KIT 3C:ML4+I-VIEW+HRP3,5/420 ML4+1-VIEW+HRP3 refs KIT 4: ML4+I-V+S-G+HRP4X/340 ML4+l-V+S-G+HRp3 refs KIT10:ML4+IV+EN50+S-G+HRP6X340 ML4+1V+EN50+SG+HRP3 refs KIT12:ML4+IV+EN50+SG+HR2,5/520 ML4+1V+EN50+S-G+HR3 refs MINI 3000 LED OPHT./OTOSC.SET MINI3000 OPHT./ OTOSC. SET2 refs MINI3000LED OPH/FO OT.RECH.SET	I MDR	EUDAMED record Report an error
Dermatoscopes	Z12040108	DELTA 20 T + CO.PL.W.SCALE DELTA 20 T + CONTACT PLATE2 refs DELTA 20 T SET/4 NT DELTA 20 T SET/4 USB+TR. DELTA 20T DELTA 20T small Contact plate3 refs 20 others DELTA 20T/KIT 1 DELTA 20T/KIT 2 DELTA 307 refs DELTA 30 PRO Bundle DELTA 30 UV DELTA 30 UV PROFESSIONAL DELTA 30 UV ULTIMATE DELTA X DELTA X CPG2 refs DELTA X DERMATOSKOP DELTA X PROFESSIONAL K-131.28.307 DELTA X ULTIMATE DELTAone STANDARD EDITION2 refs diSTANCE EN200-1 SINGLE/DELTA 20 T/KIT HEINE IC1 SET/12 Pro3 refs iC1 mini3000 LED MINI3000 LED DERM.+CONT+HA MINI3000 DERM.+CONT.PL.+HANDLE2 refs mini3000 small Contact plates3 refs	I MDR	EUDAMED record Report an error
Direct outpatient otoscopes	Z12149006	BETA 200 LED2 refs BETA 200 LED F.O. OTO.+ 4TIPS BETA OTOSCOPE + 4TlPS3 refs BETA 200 LED F.O. OTO./BETA HA.2 refs BETA 200 LED OTO./4 NT BETA LED OTO./4 NT2 refs BETA 200 LED OTO./4 USB+TR. BETA LED OTO./4 USB+TR.2 refs 15 others BETA 200 LED OTO.SET/4 NT BETA OTOSKOP SET/4 NT2 refs BETA 200 LED OTO.SET/4 USB+TR. BETA OTO. SET/4 USB+TR2 refs BETA 200 LED OTOSC.SET+BETA2 refs BETA X BETA X OTOSCOPE 3X2 refs K180 LED K180 LED F.O. OTO.+ 4 TIPS K180 F.O. OTOSCOPE + 4TlPS2 refs K180 LED OTO. SET/4 USB+TR. K180 LED OTOSCOPE SET+BETA K180 LED OTOSCOPE/BETA HA. mini 3000 F.O. LED2 refs MINI 3000 LED OTO.+HANDLE+1 X TIPS MIN13000 OTO+HAN+TIPS2 refs MINI 3000 LED OTOSC. SET MINI3000 OTO+TIPS SET2 refs MINI 3000 LED OTOSC.HANDLE + TIPS MIN13000 OTO.+HANDLE+TIPS2 refs MINI3000 LED FO OT+RECH.HA1XT.	I MDR	EUDAMED record Report an error
Ophthalmoscopes	Z12120114	A.R. 30D Ophthalmoscopy lenses BETA 200 LED OPHTH./4USB+TR. BETA 200 OPHTH./4USB+TR.2 refs BETA 200 LED OPHTH./BETA GR. BETA 200 LED OPHTHALMOSC./BETA HA. BETA 200 LED OPHTHALMOSC./BETA HA. BETA200 OPHTH.SET/4 NT2 refs BETA OPHTHALMOSCOPE SET C144/LED BETA200 OPHTH.SET+BETA2 refs 13 others BETA X BETA X OPHTHALMOSCOPE C-130.28.330 BETA-OPHTH.-SET C-144/4USB+TR. BETA 200 OPHTH.SET/4 USB+TR.2 refs K180 LED K180 LED BF. OPHTH. SET/4 USB+TR. K180 OPHTH.SET/4 USB + TR.2 refs K180 LED BF. OPHTH. SET/BETA K180 OPHTH. SET+BETA2 refs mini3000 LED MINI3000 LED OPHTH. M. LADEGR. MINI3000 LED OPHTH.W.RECH.HAN. MINI3000 LED OPHTH. M.BATT.GR. MINI3000 LED OPHTH.M.GR.+ETUI MINI3000 LED OPHTH.W.HA.+CASE MONOCULAR OMEGA 500 LED3 refs SIGMA 2502 refs	I MDR	EUDAMED record Report an error
Light sources	Z129004	EL3 LED Finoff 2,5 V LOUPEL.2 F.HR/HRP+MPACK MINI mini-c D-008.73.109 mini-e D-008.73.103 4 others mini-f D-008.73.110 ML4 LED Polarisation filter P2 for LoupeLights/MicroLights2 refs Yellow filter for LoupeLights/MicroLights2 refs	I MDR	EUDAMED record Report an error
Retinoscopes	Z12120118	BETA 200 LED RETINOSCOPE SET C342 refs BETA 200 LED RETINOSCOPE/BETA HA. BETA 200 LED ST-RET. /4USB+TR. BETA 200 ST-RET.SET/4 NT BETA X 2 others BETA X RETINOSCOPE C-140.28.330 BETA200 LED ST-RET.SET/USB+TR.	I MDR	EUDAMED record Report an error
Laryngoscopes	Z12021003	Classic+ Mac 0 Classic+ blades3 refs EasyClean LED3 refs F.O. 4 SHORT LED NT F.O. 4 rechargeable handles3 refs F.O. SLIM LED F.O. rechargeable handles3 refs F.O. SLIM LED Standard F.O. battery handles3 refs	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	HSL 150 2,5 V2 refs HSL 150 SET C-252 HSL-150-SET C-266 HSL-150/10X-SET C-267 Loupe attachment for HSL 10X	I MDR	EUDAMED record Report an error
Video laryngoscopes	Z12021004	MEDUVISION MEDUVISION Set Mac visionPRO visionPRO set Mac	I MDR	EUDAMED record Report an error

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