Reference Source

ELETTRONICA PAGANI SRL · 89-08 · ITALY

For ELETTRONICA PAGANI SRL · 89-08 · ITALY, import alert is 89-08; 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)"; country is ITALY; product is HC Cryo T-Shock | Cryoskin; product code is 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager; date published is 08/08/2022; address is Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY, verified against its source on 2026-09-16.

Firm
ELETTRONICA PAGANI 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 Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY verified
Date published
08/08/2022 verified
Product code
79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager each item verified
Product
HC Cryo T-Shock | Cryoskin each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

ELETTRONICA PAGANI SRL Date Published : 08/08/2022 Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 08/08/2022 Desc: HC Cryo T-Shock 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 08/08/2022 Desc: Cryoskin

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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