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Emdyca

Manufacturer

Hologic

United StatesLegal entities : Hologic Inc., Hologic, Inc.

First countries of placing on the market declared in EUDAMED : Belgium, Netherlands

Public contracts won : France 29, Spain 23, Italy 13, Austria 3, Germany 1, Portugal 1

EU representative : Hologic BV (Belgium)

rachelle.fitzgerald@hologic.com

45 categories, 80 models including 80 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Hysteroscopes Z12020704
12 others
 IIa 93/42 EUDAMED record Report an error
Diagnostic imaging workstations Z11069005 I, IIa MDR EUDAMED record Report an error
Electrosurgery instruments - consumables Z12010985 IIb MDR EUDAMED record Report an error
Morcellators Z12080204 IIa, IIb MDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - other W02029099 A IVDR EUDAMED record Report an error
All infectious diseases controls - NAT W0105080808 B, C IVDR EUDAMED record Report an error
Devices for samples transport - other accessories W050280 A IVDR EUDAMED record Report an error
Endometrial ablation equipment Z12080201 IIb MDR EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 C IVDR EUDAMED record Report an error
Influenza & para influenza - NA reagents W0105040504 B IVDR EUDAMED record Report an error
Infusion pumps Z12030301 IIb MDR, 93/42 EUDAMED record Report an error
Mammography systems - medical device software Z11030292 IIa MDR EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 B IVDR EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 C IVDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - hardware accessories W02029080 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699 B IVDR EUDAMED record Report an error
Beta/gamma detectors Z11029001 IIa MDR EUDAMED record Report an error
Bone densitometry systems - consumables Z11900185 I MDR EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc W0105900201 A IVDR EUDAMED record Report an error
Cervical screening systems W02020502 C IVDR EUDAMED record Report an error
Chlamydia trachomatis detection by NA reagents W0105010117 C IVDR EUDAMED record Report an error
Cmv - NA reagents W0105040205 C IVDR EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 B IVDR EUDAMED record Report an error
Genitourinary endoscopy instruments - consumables Z12020785 I MDR EUDAMED record Report an error
Gonococcal detection by NA reagents W0105010203 C IVDR EUDAMED record Report an error
Hepatitis b virus - NA reagents W0105020216 D IVDR EUDAMED record Report an error
Hepatitis c virus - NA reagents W0105020307 D IVDR EUDAMED record Report an error
HIV 1 - NA reagents W0105030107 D IVDR EUDAMED record Report an error
Hsv - NA reagents W0105040311 C IVDR EUDAMED record Report an error
Mammography systems - consumables Z11030285 I MDR EUDAMED record Report an error
Microscope slides W0503900201 A IVDR EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 C IVDR EUDAMED record Report an error
Radiosurgical units Z12010905 IIb MDR EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101 A IVDR EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 C IVDR EUDAMED record Report an error
Stain solutions (histology/cytology) W01030708 A IVDR EUDAMED record Report an error
Staphylococcal detection by NA reagents W0105011203 C IVDR EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 C IVDR EUDAMED record Report an error
Tissue processors W0202059010 A IVDR EUDAMED record Report an error
Trichomonas - NA reagents W0105050310 C IVDR EUDAMED record Report an error
Urine collection, tubes W05010202 A IVDR EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents W010501080302 C IVDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - IVD medical device software W02029092 C IVDR 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.

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