Manufacturer

SPIGGLE & THEIS Medizintechnik

GermanyLegal entities : SPIGGLE & THEIS Medizintechnik GmbH

Markets : Germany · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 1 · class I, II · latest in 2023 · see on the FDA website

9 categories, 15 models including 15 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Various ENT instruments - hardware accessories	Z12149080	HighSpeed Handpieces3 refs93/42 LowSpeed Handpieces5 refs93/42 Nozzles2 refs Shaver Handpieces93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	HighSpeed Electronic Motor93/42 LowSpeed Electronic Motor93/42 Micro Drill- and Shaver-Systems and Accessories2 refs93/42	IIa 93/42	EUDAMED record Report an error
Laryngoscopes	Z12021003	Laryngoscopes & accessories3 refs Rigid Endoscopes17 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Bronchoscopes	Z12020801	Rigid Endoscopes8 refs93/42	IIa 93/42	EUDAMED record Report an error
Implant measurement devices not included in other classes	V030204	Test weights for Lid implants3 refs	I MDR	EUDAMED record Report an error
Liposuction systems	Z12040214	Lipo harvesting-set (sterile)93/42	IIa 93/42	EUDAMED record Report an error
Middle ear otoscopes	Z12021007	Rigid Endoscopes18 refs93/42	IIa 93/42	EUDAMED record Report an error
Nasal pharyngo/laryngoscopes	Z12021005	Flexible Endoscopes2 refs	I MDR	EUDAMED record Report an error
Rhinoscopes	Z12021008	Rigid Endoscopes28 refs93/42	IIa 93/42	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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.