Manufacturer

Gimmi

GermanyLegal entities : Gimmi GmbH

Markets : Germany · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 7 · class I, II · latest in 2026 · see on the FDA website

Website

14 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
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Genitourinary endoscopy instruments - other	Z12020799	CYSTOSCOPE-URETHROSCOPE ALBARRAN2 refs93/42 CYSTOSCOPE-URETHROSCOPE SHEATH+OBTURATOR5 refs93/42 INNER SHEATH FOR EXAMINATION T.9056.7993/42 NEPHROSCOPE, SHEATH AND OBTURATOR T.9600.3093/42 NEPHROSCOPE, SHEATH AND OBTURATOR T.9600.3393/42 1 other OPTICAL INSTRUMENT SHEATH T.9056.7893/42	IIa 93/42	EUDAMED record Report an error
Laser surgery instruments - other	Z12011099	GUIDING PIPE8 refs93/42 LASER WORKING ELEMENT93/42 LASER WORKING ELEMENT PASSIVE4 refs93/42 LASER WORKING INSERT93/42	IIa 93/42	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	ALPHALED AlphaSMART AlphaSMART Light Source Light source E.8230.35 LED3 refs	I MDR	EUDAMED record Report an error
Gas inflators	Z12029008	ALPHADUOLAP CO2 HEATING TUBE2 refs93/42 ALPHADUOLAP INSUFFLATOR 30 L SET3 refs93/42 ALPHADUOLAP INSUFFLATOR 45 L SET4 refs93/42	IIa 93/42	EUDAMED record Report an error
Laparoscopes	Z12029009	AlphaScope™22 refs93/42 AlphaScope™ ALPHASCOPE 4HD LAPAROSCOPE12 refs93/42 AlphaScope™ REXFLAT ALPHASCOPE 4HD LAPAROSCOPE12 refs93/42	IIa 93/42	EUDAMED record Report an error
Nephroscopes	Z12020705	NEPHROSCOPE 45° ANGELED OCULAR93/42 NEPHROSCOPE 45° ANGLED OCULAR3 refs93/42 NEPHROSCOPE 90° ANGLED OCULAR4 refs93/42	IIa 93/42	EUDAMED record Report an error
Surgical cameras	Z12020405	ALPHANOVOCAM3 refs AlphaSMART3 refs Camera and TV adapter3 refs	I MDR	EUDAMED record Report an error
Ureterorenoscopes	Z12020713	URETERO-RENOSCOPE HD2 refs93/42 URETERO-RENOSCOPE HD, THIN2 refs93/42 URETERO-RENOSCOPE HD, ULTRA THIN93/42	IIa 93/42	EUDAMED record Report an error
Arthroscopes	Z12021101	AlphaScope™25 refs93/42 AlphaScope™ ALPHASCOPE 4HD ARTHROSCOPE3 refs93/42	IIa 93/42	EUDAMED record Report an error
Laryngoscopes	Z12021003	AlphaScope™3 refs Laryngoscope, Otoscope and Accessories AV.1350.003 refs	I MDR	EUDAMED record Report an error
Cystoscopes	Z12020701	AlphaScope™14 refs93/42	IIa 93/42	EUDAMED record Report an error
Direct outpatient otoscopes	Z12149006	AlphaScope™3 refs	I MDR	EUDAMED record Report an error
Hysteroscopes	Z12020704	AlphaScope™93/42	IIa 93/42	EUDAMED record Report an error
Proctoscopes	Z12020603	Surgical Instrument PU.1678.013 refs	I MDR	EUDAMED record Report an error

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