Quadra Medical SRL · 89-08 · ITALY
For Quadra Medical SRL, import alert is 89-08; country is ITALY; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 11/21/2012; address is VIA NARDA 38, 98 Romano D'Ezzelino , VIA CARTIGLIANA 143B , Venice, IT-VI ITALY, verified against its source on 2026-09-30.
- Firm
- Quadra Medical SRL verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- ITALY verified
- Address
- VIA NARDA 38, 98 Romano D'Ezzelino , VIA CARTIGLIANA 143B , Venice, IT-VI ITALY verified
- Date published
- 11/21/2012 verified
- Product code
- 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
- FDA notes
- All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III | All medical devices class I/II/III each item verified
What the source says
Quadra Medical SRL Date Published : 11/21/2012 VIA NARDA 38, 98 Romano D'Ezzelino , VIA CARTIGLIANA 143B , Venice, IT-VI ITALY
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
73 - - - -- Anesthesiology Date Published: 11/21/2012 Notes: All medical devices class I/II/III 74 - - - -- Cardiovascular Date Published: 11/21/2012 Notes: All medical devices class I/II/III 76 - - - -- Dental Date Published: 11/21/2012 Notes: All medical devices class I/II/III 77 - - - -- Ear,Nose And Throat Date Published: 11/21/2012 Notes: All medical devices class I/II/III 78 - - - -- Gastroenterological & Urological Date Published: 11/21/2012 Notes: All medical devices class I/II/III 79 - - - -- General & Plastic Surgery Date Published: 11/21/2012 Notes: All medical devices class I/II/III 80 - - - -- General Hospital/Personal Use Date Published: 11/21/2012 Notes: All medical devices class I/II/III 84 - - - -- Neurological Date Published: 11/21/2012 Notes: All medical devices class I/II/III 85 - - - -- Obstetrical & Gynecological Date Published: 11/21/2012 Notes: All medical devices class I/II/III 86 - - - -- Ophthalmic Date Published: 11/21/2012 Notes: All medical devices class I/II/III 87 - - - -- Orthopedic Date Published: 11/21/2012 Notes: All medical devices class I/II/III 89 - - - -- Physical Medicine Date Published: 11/21/2012 Notes: All medical devices class I/II/III 90 - - - -- Radiology Date Published: 11/21/2012 Notes: All medical devices class I/II/III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html