Instruments for functional explorations and therapeutic interventionsENT instrumentsVarious ENT instruments

Various ENT instruments - hardware accessories

EMDN code Z12149080

17 manufacturers, 76 models including 76 on the market, 8 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 17

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Bienair FDA EU representative : Bien-Air Europe Sàrl (France)	Switzerland	0.35mm S2 Mini PERFORATOR BUR93/42 0.5mm S2 Mini CARBIDE ROUND BUR93/42 0.6mm S2 Mini CARBIDE ROUND BUR93/42 0.6mm S2 Mini DIAMOND ROUND BUR93/42 0.7mm S2 Mini CARBIDE ROUND BUR93/42 12 others 0.7mm S2 Mini DIAMOND ROUND BUR93/42 0.8mm S2 Mini CARBIDE ROUND BUR93/42 0.8mm S2 Mini DIAMOND ROUND BUR93/42 1.0mm S2 Mini CARBIDE ROUND BUR93/42 1.0mm S2 Mini DIAMOND ROUND BUR93/42 1.2mm S2 Mini DIAMOND ROUND BUR93/42 1.4mm S2 Mini CARBIDE ROUND BUR93/42 1.4mm S2 Mini DIAMOND ROUND BUR93/42 1.8mm S2 Mini CARBIDE ROUND BUR93/42 1.8mm S2 Mini DIAMOND ROUND BUR 1.8mm S2Mini DIAMOND ROUND BUR93/42 2.3mm S2 Mini CARBIDE ROUND BUR93/42 2.3mm S2 Mini DIAMOND ROUND BUR93/42	IIa 93/42	Website EUDAMED record Report an error
Nouvag FDA EU representative : Nouvag GmbH (Germany)	Switzerland	Angled High-Speed surgical handpiece 1:1 FG shank ø 2.35 mm, L= 125mm93/42 Angled High-Speed surgical handpiece 1:1 FG shank ø 2.35 mm, L= 70mm93/42 Angled High-Speed surgical handpiece 1:1 FG shank ø 2.35 mm, L= 95mm93/42 Angled surgical handpiece 1:1, FG shank ø 2.35 mm, L= 125 mm93/42 Angled surgical handpiece 1:1, FG shank ø 2.35 mm, L= 70 mm93/42 9 others Angled surgical handpiece 1:1, FG shank ø 2.35 mm, L= 95 mm93/42 High-speed surgical handpiece 1:1, FG shank ø 2.35 mm, L= 70mm93/42 High-speed surgical handpiece 1:1, FG shank ø 2.35 mm, L= 125mm93/42 High-speed surgical handpiece 1:1, FG shank ø 2.35 mm, L= 95mm93/42 Shaver handpiece ENT93/42 Surgical handpiece 1:1, FG shank ø 2,35 mm, L = 125 mm93/42 Surgical handpiece 1:1, FG shank ø 2.35 mm, L= 70 mm93/42 Surgical handpiece 1:1, FG shank ø 2.35 mm, L= 95 mm93/42 Surgical handpiece 1:1, FG shank Ø 2.35 mm, L=44 mm93/42	IIa 93/42	Website EUDAMED record Report an error
Gyrus ACMI FDA EU representative : Olympus Europa SE & Co. KG (Germany)	United States	ENT Microdebrider accessories ICLIP20093/42 MDALA93/42 MDASA93/42 MDHP100A93/42 6 others MDHP100S93/42 MDHP20093/42 MDSLA93/42 MDSSA93/42 MDSTAP93/42 NCGRIP93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
PENTAX of America FDA EU representative : PENTAX Europe GmbH (Germany)	United States	Adult Face Mask, Extra 6602 Adult Large Disposable Masks 66253 refs Airflow Head‑Mask Couplers 66102 refs Flowhead Tubes 66113 refs Flowhead, Extra 6601 4 others Microphone Assembly Kit 6651 Pediatric Disposable Masks 6615 Pediatric Mask with Adaptor 6606 Switch Box Assembly A‑B 7190-2500	I MDR	EUDAMED record Report an error
Dgs Diagnostics A S	Denmark	B-813 refs B713 refs CIR insert earphone3 refs DD453 refs DD4503 refs 2 others DD65v23 refs RadioEar IP303 refs	IIa MDR	ra_product-lifecycle@dgs-diagnostics.com EUDAMED record Report an error
SPIGGLE & THEIS Medizintechnik FDA	Germany	HighSpeed Handpieces3 refs93/42 LowSpeed Handpieces5 refs93/42 Nozzles2 refs Shaver Handpieces93/42	I, IIa MDR, 93/42	Website info@spiggle-theis.com EUDAMED record Report an error
Inventis FDA	Italy	easyTymp-Docking Station Maestro Control Panel Timpani-Docking Station	I MDR	Website quality@inventis.it EUDAMED record Report an error
Pathme FDA	Germany	BC-013 refs IP-05M2 refs	IIa MDR	Website info@pathme.de EUDAMED record Report an error
Auditdata FDA	Denmark	3000 Real Ear BC1 - 2000-1 3000 Real Ear BC1, IN1, CA1, SA13 refs	IIa MDR	Website compliance@auditdata.com EUDAMED record Report an error
Bionix FDA EU representative : Obelis s.a. (Belgium)	United States	Magnification Lens	I MDR	Website EUDAMED record Report an error
FIM Medical FDA	France	Earpad covers FF1075	I MDR	Website contact@fim-medical.com EUDAMED record Report an error
Interacoustics FDA	Denmark	Interacoustics Touch keyboard	I MDR	Website info@interacoustics.com EUDAMED record Report an error
Karlstorz FDA	Germany	Probes/Bougies/Dilators6 refs	I MDR	Website regulatory@karlstorz.com EUDAMED record Report an error
Keeler FDA EU representative : Keeler Europe Distribution, S.L. (Spain)	United Kingdom (ex Northern Ireland)	"DISPOSABLE SPECULA 6X 3.5MM/6X 5.5MM (PK OF 12)"3 refs	I MDR	Website regulatory@keeler.co.uk EUDAMED record Report an error
Luxamed FDA	Germany	Disposable Ear Funnels3 refs	I MDR	Website info@luxamed.de EUDAMED record Report an error
Medi-Care Solutions	Italy	POLTRONA PER VISITE OTORINOLARINGOIATRICHE2 refs	I MDR	Website EUDAMED record Report an error
Roboptics	Portugal	uRecorder URC012 refs	I MDR	Website EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 3

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Glottal Enterprises, Inc.	United States	Two Channel Electroglottograph EG2-PCX2	registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories	United States	Medline	registered
HOYA Corporation PENTAX Division	United States	–	registered

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