Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

BK MEDICAL APS

DENMARK

9680269

2026

transducer, ultrasonic, diagnostic - 1300 (bkSpecto); 9002 (9C2); 9008 (E11C3b); 9009 (X18L5s); 9011 (13L4w); 9015 (I14C5I); 9016 (I14C5T); 9018 (E14C4t); 9019 (E10C4); 9023 (6C2s); 9024 (I12C5b); 9026 (X12C4); 9029 (E13C2); 9032 (8L2); 9038 (X14L4); 9040 (6C2); 9048 (E14CL4b); 9051 (14L3); 9052 (20R3); 9062 (N13C5); 9063 (N11C5s); 9070 (18L5); 9081 (18L5s); 9085 (5C1e); 9086 (14L3e); 9087 (5P1e); UA0671 (Water Standoff); UA0672 (Rectosygmoidoscope); UA0673 (Rectosygmoidoscope); UA1232; UA1239; UA1250; UA1251; UA1282; UA1324; UA1325 (Channel Bracket); UA1325w (Channel Bracket); UA1326; UA1327; UA1328; UA1349

Manufacturer; Specification Developer

system, imaging, pulsed doppler, ultrasonic - 1300 (bkSpecto); 9002 (9C2); 9008 (E11C3b); 9009 (X18L5s); 9011 (13L4w); 9015 (I14C5I); 9016 (I14C5T); 9018 (E14C4t); 9019 (E10C4); 9023 (6C2s); 9024 (I12C5b); 9026 (X12C4); 9029 (E13C2); 9032 (8L2); 9038 (X14L4); 9040 (6C2); 9048 (E14CL4b); 9051 (14L3); 9052 (20R3); 9062 (N13C5); 9063 (N11C5s); 9070 (18L5); 9081 (18L5s); 9085 (5C1e); 9086 (14L3e); 9087 (5P1e); UA0671 (Water Standoff); UA0672 (Rectosygmoidoscope); UA0673 (Rectosygmoidoscope); UA1232; UA1239; UA1250; UA1251; UA1282; UA1324; UA1325 (Channel Bracket); UA1325w (Channel Bracket); UA1326; UA1327; UA1328; UA1349

Manufacturer; Specification Developer

system, imaging, pulsed echo, ultrasonic - 1300 (bkSpecto); 9002 (9C2); 9008 (E11C3b); 9009 (X18L5s); 9011 (13L4w); 9015 (I14C5I); 9016 (I14C5T); 9018 (E14C4t); 9019 (E10C4); 9023 (6C2s); 9024 (I12C5b); 9026 (X12C4); 9029 (E13C2); 9032 (8L2); 9038 (X14L4); 9040 (6C2); 9048 (E14CL4b); 9051 (14L3); 9052 (20R3); 9062 (N13C5); 9063 (N11C5s); 9070 (18L5); 9081 (18L5s); 9085 (5C1e); 9086 (14L3e); 9087 (5P1e); UA0671 (Water Standoff); UA0672 (Rectosygmoidoscope); UA0673 (Rectosygmoidoscope); UA1232; UA1239; UA1250; UA1251; UA1282; UA1324; UA1325 (Channel Bracket); UA1325w (Channel Bracket); UA1326; UA1327; UA1328; UA1349

Manufacturer; Specification Developer

transducer, ultrasonic, diagnostic - 2300 (bk3000, bk3500, bk5000, bkActiv); 9002 (9C2); 9007 (N20P6); 9009 (X18L5s); 9011 (13L4w); 9015 (I14C5I); 9016 (I14C5T); 9018 (E14C4t); 9019 (E10C4); 9023 (6C2s); 9024 (I12C5b); 9026 (X12C4); 9029 (E13C2); 9032 (8L2); 9034 (I12C5); 9038 (X14L4); 9040 (6C2); 9048 (E14CL4b); 9051 (14L3); 9052 (20R3); 9062 (N13C5); 9063 (N11C5s); 9066 (I12C4f); 9070 (18L5); 9076 (I13C3f); 9077 (5P1); 9078 (l13C3fx); 9081 (18L5s); 9085 (5C1e); 9096 (Rob12C4); bkActiv S Series; UA0671 (Water Standoff); UA0672 (Rectosigmoidoscope); UA0673 (Rectosigmoidoscope); UA1232; UA1239; UA1250; UA1251; UA1282; UA1324; UA1325 (Channel Bracket); UA1325w (Channel Bracket); UA1326; UA1327; UA1328; UA1349; UA2379 Integrated TR Fusion Kit 2300; UA2390 Integrated TP Fusion Kit 2300

Manufacturer; Specification Developer

system, imaging, pulsed doppler, ultrasonic - 2300 (bk3000, bk3500, bk5000, bkActiv); 9002 (9C2); 9007 (N20P6); 9009 (X18L5s); 9011 (13L4w); 9015 (I14C5I); 9016 (I14C5T); 9018 (E14C4t); 9019 (E10C4); 9023 (6C2s); 9024 (I12C5b); 9026 (X12C4); 9029 (E13C2); 9032 (8L2); 9034 (I12C5); 9038 (X14L4); 9040 (6C2); 9048 (E14CL4b); 9051 (14L3); 9052 (20R3); 9062 (N13C5); 9063 (N11C5s); 9066 (I12C4f); 9070 (18L5); 9076 (I13C3f); 9077 (5P1); 9078 (l13C3fx); 9081 (18L5s); 9085 (5C1e); 9096 (Rob12C4); bkActiv S Series; UA0671 (Water Standoff); UA0672 (Rectosigmoidoscope); UA0673 (Rectosigmoidoscope); UA1232; UA1239; UA1250; UA1251; UA1282; UA1324; UA1325 (Channel Bracket); UA1325w (Channel Bracket); UA1326; UA1327; UA1328; UA1349; UA2379 Integrated TR Fusion Kit 2300; UA2390 Integrated TP Fusion Kit 2300

Manufacturer; Specification Developer

Show all 18 Listings for BK MEDICAL APS DENMARK

Datex-Ohmeda, Inc.

WI/USA

2112667

2026

ventilator, continuous, facility use - GE DATEX-OHMEDA ENGSTROM CARESTATION

Manufacturer

gas-machine, anesthesia - Aisys; Aisys Carestation

Manufacturer

vaporizer, anesthesia, non-heated - Tec 7 Anesthesia Vaporizer

Manufacturer

gas-machine, anesthesia - Aestiva MRI; Aestiva/5 MRI

Manufacturer

vaporizer, anesthesia, non-heated - Tec 6 Plus Anesthesia Vaporizer

Manufacturer

Show all 48 Listings for Datex-Ohmeda, Inc. WI/USA

Datex-Ohmeda, Inc.

WI/USA

3014220748

2026

unit, neonatal phototherapy - Blue Spot PT; Blue Spot PT Lite; Giraffe Blue Spot PT Lite

Specification Developer

unit, neonatal phototherapy - BiliSoft; BiliSoft 2.0 Phototherapy System; BiliSoft LED Phototherapy System; BiliSoft Phototherapy System

Specification Developer

warmer, infant radiant - Disposable Infant Skin Temperature Probe; Giraffe OmniBed Carestation; Giraffe OmniBed Carestation CS1; Giraffe Panda Disposable Infant Skin Temperature Probe

Specification Developer

incubator, neonatal - Disposable Infant Skin Temperature Probe; Giraffe OmniBed Carestation; Giraffe OmniBed Carestation CS1; Giraffe Panda Disposable Infant Skin Temperature Probe

Specification Developer

incubator, neonatal - Disposable Infant Skin Temperature Probe; Giraffe Incubator Carestation; Giraffe Incubator Carestation CS1; Giraffe Panda Disposable Infant Skin Temperature Probe

Specification Developer

Show all 32 Listings for Datex-Ohmeda, Inc. WI/USA

Datex-Ohmeda, Inc.

WI/USA

3036470679

2026

stand, infusion - IV Pole; IV POLE ASSY 12 IN 12 Inch IV1; IV POLE ASSY 24 IN 24 Inch IV1; LULLABY IV POLE IV1; ROTATING IV POLE Rotating IV1

Specification Developer

unit, neonatal phototherapy - BiliSoft; BiliSoft 2.0 Phototherapy System; BiliSoft LED Phototherapy System; BiliSoft Phototherapy System

Specification Developer

unit, neonatal phototherapy - Blue Spot PT; Blue Spot PT Lite; Giraffe Blue Spot PT Lite

Specification Developer

incubator, neonatal - Giraffe Incubator; Giraffe Incubator + Shuttle; Giraffe Shuttle

Specification Developer

unit, neonatal phototherapy - Lullaby LED Phototherapy System; Lullaby LED PT

Specification Developer

Show all 32 Listings for Datex-Ohmeda, Inc. WI/USA

GE BE PRIVATE LTD.

INDIA

9617766

2026

generator, high-voltage, x-ray, diagnostic - BONZAI; CT MINI; Djinn Beetle; Djinn Mammo; Djinn Tonix; DMR; GAIA INTERVENTIONAL GENERATOR; Jedi; Jedi 100 VASC 1; JEDI 100 VASC 1T; Jedi 42 CT; Jedi 50 Plus R1T; Jedi 50 R 1T; Jedi 60 CT; Jedi 60 DC; JEDI 60 DC LITE; Jedi 60DC; Jedi 60DC Lite; Jedi 80 R 1T; Jedi 80 RD 1T; Jedi 80 RF 1T; Jedi 80 RF 2T; JEDI 80 RF1T; JEDI HP; Jedi NP+V1.5; JEDI SC FAST kV; JEDI VCT; Jedi42CT; Jedi50R1T; Jedi60CT; Jedi80R1T; Jedi80RF1T; Jedi80RF2T; MPG100; MPG50; MPPU; Prisme; Prodigy/DPX Series High Voltage Power Supply; SYJ; TTH; TTH 8800; TTH HAWKEYE; TTH MAESTRO; VAMP; VMX; X-Ray Generator; ZEUS; ZEUS, ZJ/QJ; ZJ/QJ; Zyx

Manufacturer; Specification Developer

assembly, tube housing, x-ray, diagnostic - 40782; 43318; 45645; 5855555; APOLLON; Artemis; Brivo OEC 2.2A X-ray Generator; Ergo MONOBLOCK; LU40782; LU43318ST; LU45645; LU45645ST; LU45645STR; LU45649; LU45649ST; LU45649STR; LU8548ST; LU8548STR; LU8743ST; LU8743STR; MAXIRAY 100 TH-M1; Maxiray CT Ultra; Maxiray CT VCT; Maxiray MX100 FL; Maxiray MX100 RAD; MX100 FL; MX100 RAD; MX135CT TH1.1; MX165 NP; MX200CT/Performix Ultra; Performix 160A; Performix 40; Performix 40 Plus; Performix HD; Performix HD Plus; Performix HDw; Performix Plus; Performix Pro VCT 100; Performix Pulsar; Performix VCT Plus; Quantix 160; SB-80-200R; Solarix 350 Brightspeed; Vamana RAD; Vamana Surgery

Manufacturer; Specification Developer

GE HANGWEI MEDICAL SYSTEMS CO., LTD.

CHINA

9613445

2026

system, x-ray, stationary - Proteus XR/a

Manufacturer

system, x-ray, tomography, computed - Operator Console for BrightSpeed Elite_BrightSpeed Elite Select; Optima CT540

Manufacturer

system, x-ray, tomography, computed - Enhanced Extream Injector Option; Extream Injector Option

Manufacturer

holder, radiographic cassette, wall-mounted - WALL MOUNTED CASSETTE HOLDER Wallstand for X-Ray System; Wallstand (GCMWS-C5); Wallstand (Model: GCEWS-C4); Wallstand (Model: GCWS-C3; GCWS-C5; GCWS-C6); Wallstand (Model: VMWS-1; VMWS-2)

Manufacturer

system, x-ray, tomography, computed - Discovery CT590 RT; Discovery RT; Optima CT580; Optima CT580 RT; Optima CT580 W

Manufacturer

Show all 104 Listings for GE HANGWEI MEDICAL SYSTEMS CO., LTD. CHINA

GE HEALTHCARE

IL/USA

3004526608

2026

system, image processing, radiological - Centricity Radiology RA600 / Centricity Cardiology CA1000 / DHC; Centricity Radiology RA600, Centricity Cardiology CA 1000, and Digital Hardcopy

Manufacturer

system, image processing, radiological - Centricity AW Suite

Manufacturer

system, image processing, radiological - Centricity PACS IW

Manufacturer

system, image processing, radiological - Centricity PACS Web Diagnostic

Manufacturer

system, image processing, radiological - Centricity Cardio Imaging

Manufacturer

Show all 23 Listings for GE HEALTHCARE IL/USA

GE Healthcare (China) Co., Ltd.

CHINA

3008284470

2026

system, nuclear magnetic resonance imaging - SIGNA Creator; SIGNA Explorer; SIGNA Explorer Quantum; SIGNA MR355; SIGNA MR360

Specification Developer

system, nuclear magnetic resonance imaging - 1.5T Anterior Array; 1.5T TDI Head Neck Array; 1.5T TDI Posterior Array; SIGNA Voyager; SIGNA Voyager Quantum

Specification Developer

coil, magnetic resonance, specialty - 1.5T Anterior Array; 1.5T TDI Head Neck Array; 1.5T TDI Posterior Array; SIGNA Voyager; SIGNA Voyager Quantum

Specification Developer

system, x-ray, angiographic - 3DXR; Discovery IGS 7; Discovery IGS 7 OR; DISCOVERY IGS 730; INNOVA 2100-IQ; INNOVA 2121-IQ; INNOVA 3100-IQ; INNOVA 3131-IQ; INNOVA 4100-IQ; Innova IGS 5; INNOVA IGS 520; INNOVA IGS 530; INNOVA IGS 540; Innova IGS 6; INNOVA IGS 620; INNOVA IGS 630; Optima CL320i; Optima CL323i; Optima IGS 320; Optima IGS 330

Specification Developer

system, x-ray, fluoroscopic, image-intensified - 3DXR; Discovery IGS 7; Discovery IGS 7 OR; DISCOVERY IGS 730; INNOVA 2100-IQ; INNOVA 2121-IQ; INNOVA 3100-IQ; INNOVA 3131-IQ; INNOVA 4100-IQ; Innova IGS 5; INNOVA IGS 520; INNOVA IGS 530; INNOVA IGS 540; Innova IGS 6; INNOVA IGS 620; INNOVA IGS 630; Optima CL320i; Optima CL323i; Optima IGS 320; Optima IGS 330

Specification Developer

Show all 112 Listings for GE Healthcare (China) Co., Ltd. CHINA

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

CHINA

3010949642

2026

system, nuclear magnetic resonance imaging - 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY; 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY; 16CH Express HNA coil; 8ch Express PA coil; 9E Express AA coil

Specification Developer

system, nuclear magnetic resonance imaging - SIGNA Creator; SIGNA Explorer; SIGNA Explorer Quantum; SIGNA MR355; SIGNA MR360

Manufacturer

coil, magnetic resonance, specialty - 1.5T 4CH Large Flex Coil; 1.5T 4CH Small Flex Coil

Manufacturer

system, nuclear magnetic resonance imaging - 8ch Express Suite; Brivo MR355; EXPRESS COIL - ANTERIOR ARRAY; EXPRESS COIL - HEAD NECK ARRAY; EXPRESS COIL - POSTERIOR ARRAY; Optima MR360

Specification Developer

system, nuclear magnetic resonance spectroscopic - 8ch Express Suite; Brivo MR355; EXPRESS COIL - ANTERIOR ARRAY; EXPRESS COIL - HEAD NECK ARRAY; EXPRESS COIL - POSTERIOR ARRAY; Optima MR360

Specification Developer

Show all 70 Listings for GE HEALTHCARE (TIANJIN) COMPANY LIMITED CHINA

GE Healthcare Austria GmbH & Co OG

AUSTRIA

8020021

2026

transducer, ultrasonic, diagnostic - 4D5C-L; LOGIQ P6; LOGIQ P6 Pro

Manufacturer

system, imaging, pulsed doppler, ultrasonic - 4D5C-L; LOGIQ P6; LOGIQ P6 Pro

Manufacturer

system, imaging, pulsed echo, ultrasonic - 4D5C-L; LOGIQ P6; LOGIQ P6 Pro

Manufacturer

transducer, ultrasonic, diagnostic - Voluson E6; Voluson E8

Manufacturer

system, imaging, pulsed doppler, ultrasonic - Voluson E6; Voluson E8

Manufacturer

Show all 211 Listings for GE Healthcare Austria GmbH & Co OG AUSTRIA

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Establishment Registration & Device Listing

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