Zhermack S.p.A.
IT-MF-000011215 · Italy · Badia Polesine (RO)
Zhermack S.p.A. is registered in the European database on medical devices as a manufacturer, with 254 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 254 |
|---|
Devices declared under this manufacturer
- Box for Alginates
- CLINIX INTRA-ORAL NOZZLES
- FREEALGIN
- FREEALGIN MAXI EXTRA FAST
- HYDRORISE EXTRA LIGHT BODY FAST SET
- HYDRORISE PUTTY NORMAL SET
- HYDROSOFT PUTTY SOFT FAST SET
- ORTHOPRINT
- PERFEXIL PLATINIUM+ PUTTY SUPER SOFT FAST
- PRINT 0 PRO CHROMO
- PRINT 0 PRO FAST SETTING
- R&S INTRA-ORAL TIPS
Showing 12 of 254 declared devices.
Catalogue references include 11012Q, 3139031, 3175844, C207003, C207012, C300106.
European nomenclature codes declared: Q01020102, Q010280, Q01020101, Q01020104, D0799, D0902.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ZHERMACK S.P.A. (IT) · FDA 9614794 |
| Devices in EUDAMED | 254 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 254 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ZHERMACK S.P.A. |
North American profile: Both markets. Zhermack S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 053618 0030 | reissued | 2031-10-20 |
G10 053618 0028 | issued | 2026-10-20 |