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Sign in to claim this brandHENRY SCHEIN, INC.
United States·US-MF-000021683
Last updated May 30, 2026
Information
- Country
- United States
- Address
- 135, Duryea Road, Melville, United States
- Website
- henryschein-dental.de
- —
- —
- [email protected]
- Phone
- +1(732)918-0770
- PRRC Contact
- Tracey Alexander
- EUDAMED SRN
- US-MF-000021683
- FDA FEI Number
- —
- DUNS Number
- 012430880
Catalogue (11456)
Page 1 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Krugg | 959502 | EUDAMED | Class I | Active |
| Krugg | 959501 | EUDAMED | Class I | Active |
| Krugg | 959456 | EUDAMED | Class I | Active |
| Krugg | 959342 | EUDAMED | Class I | Active |
| Krugg | 959457 | EUDAMED | Class I | Active |
| Henry Schein Maxima | 5724744 | EUDAMED | Class IIa | Active |
| Henry Schein | 5723930 | EUDAMED | Class IIa | Active |
| Krugg | 959458 | EUDAMED | Class I | Active |
| Krugg | 959455 | EUDAMED | Class I | Active |
| Krugg | 959991 | EUDAMED | Class I | Active |
| Krugg | 959500 | EUDAMED | Class I | Active |
| Krugg | 959341 | EUDAMED | Class I | Active |
| Krugg | 959343 | EUDAMED | Class I | Active |
| Krugg | 959480 | EUDAMED | Class I | Active |
| Krugg | 959482 | EUDAMED | Class I | Active |
| Hsm | 9008684 | EUDAMED | Class I | Active |
| Hs | 9006699 | EUDAMED | Class I | Active |
| Hs | 5723667 | EUDAMED | Class I | Active |
| Hs | 9001280 | EUDAMED | Class IIa | Active |
| Krugg | 959990 | EUDAMED | Class I | Active |
| Hs | 9882140 | EUDAMED | Class I | Active |
| Hs | 9001279 | EUDAMED | Class IIa | Active |
| Krugg | 959340 | EUDAMED | Class I | Active |
| Krugg | 959481 | EUDAMED | Class I | Active |
| Hs | 9006698 | EUDAMED | Class I | Active |
| Hs | 9006696 | EUDAMED | Class I | Active |
| Hs | 9008990 | EUDAMED | Class IIa | Active |
| Hs | 9009750 | EUDAMED | Class IIa | Active |
| Krugg | 959503 | EUDAMED | Class I | Active |
| Henry Schein | 9007172 | FDA UDI | Class I | Active |
| Henry Schein | 9007081 | FDA UDI | Class I | Active |
| Henry Schein | 5700010 | FDA UDI | Class I | Active |
| Henry Schein | 9011434 | FDA UDI | Class II | Active |
| Zirlux | 9010391 | FDA UDI | Class II | Active |
| Henry Schein Maxima | 1126609 | FDA UDI | Class I | Active |
| Henry Schein | 9011250 | FDA UDI | Class II | Active |
| Henry Schein | 1004612 | FDA UDI | Class II | Active |
| Henry Schein | 1016767 | FDA UDI | Class I | Active |
| Henry Schein | 2020335 | FDA UDI | Class I | Active |
| Henry Schein | 009007491 | FDA UDI | Class I | Active |
| Henry Schein Maxima | 1126541 | FDA UDI | Class I | Active |
| Henry Schein | 5702689 | FDA UDI | Class II | Active |
| Henry Schein | 9012002 | FDA UDI | Class II | Active |
| Aloesoft Plus Nitrile PF | 1126406 | FDA UDI | Class I | Active |
| Henry Schein Essentials | 1127281 | FDA UDI | Class II | Active |
| Henry Schein | 5700997 | FDA UDI | Class I | Active |
| Henry Schein | 5705438 | FDA UDI | Class II | Active |
| Henry Schein | 5703413 | FDA UDI | Class I | Active |
| Henry Schein | 5702172 | FDA UDI | Class II | Active |
| Zirlux | 9011301 | FDA UDI | Class II | Active |
Related Companies
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 10, 2011 | Z-0390-2012 | — | terminated | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| Jun 27, 2003 | Z-1046-03 | — | terminated | FDA's analysis revealed defects (holes) in the latex gloves. |
| Jun 27, 2003 | Z-1045-03 | — | terminated | FDA's analysis revealed defects (holes) in the latex gloves. |