Manufacturer

Bk Medical Aps

DenmarkLegal entities : BK Medical ApS

Markets : Denmark · France · Italy · United States

Approvals : EU – class I, IIa, IIb, III · United States (FDA) – 510(k) : 35 · class II · latest in 2023 · see on the FDA website

Public contracts won : France 18 · Italy 2

eudamed@gehealthcare.com

8 categories, 34 models including 34 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
Ultrasound probes - other	Z11040299	I12C4f Intraoperative laparoscopic transducer93/42 I12C5 Intraoperative transducer93/42 I12C5b Intraoperative transducer93/42 I13C3f Intraoperative laparoscopic transducer93/42 I14C5I I14C5l Intraoperative transducer93/42 6 others I14C5T Intraoperative transducer93/42 N11C5s Neurosurgical transducer93/42 N13C5 Neurosurgical transducer93/42 Rob12C4 Intraoperative transducer93/42 X12C4 Intraoperative transducer93/42 X18L5s Hockey Stick Transducer93/42	IIa, III 93/42	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	13L4w Surface transducer93/42 14L3 Surface transducer93/42 14L3e Surface transducer93/42 18L5 Surface transducer93/42 18L5s Surface transducer93/42 1 other 8L2 Surface transducer93/42	IIa 93/42	EUDAMED record Report an error
Endocavitary ultrasound probes, two-dimensional	Z1104020201	E10C4 Endocavity transducer93/42 E11C3b Endocavity transducer93/42 E13C2 Endocavity transducer93/42 E14C4t Endocavity transducer93/42 E14CL4b Endocavity transducer93/42	IIa, IIb 93/42	EUDAMED record Report an error
Curvilinear transcutaneous two-dimensional ultrasound probes (convex-array)	Z110402010201	5C1e Surface transducer93/42 6C2 Surface transducer93/42 9C2 Surface transducer93/42	IIa 93/42	EUDAMED record Report an error
Various ultrasound instruments - other	Z11049099	Rectosigmoidoscope with Obturator2 refs UA1325-W Dummy Channel Bracket93/42 Water Standoff Collar	I, IIa MDR, 93/42	EUDAMED record Report an error
Endocavitary ultrasound probes, multidimensional	Z1104020202	20R3 Endocavity transducer93/42 X14L4 Endocavity transducer93/42	IIa 93/42	EUDAMED record Report an error
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	bkActiv, bkActiv S Series, bk3000, bk500093/42 bkSpecto93/42	IIb 93/42	EUDAMED record Report an error
Transcutaneous ultrasound sector probes (phased array), two-dimensional	Z110402010301	5P1 Surface transducer93/42 5P1e Surface transducer	IIa, IIb MDR, 93/42	EUDAMED record Report an error

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