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Sign in to claim this brandEpocal Inc
US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- siemens-healthineers.com
- —
- —
- [email protected]
- Phone
- +1(877)229-3711
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 201179681
Catalogue (60)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Epoc Host, Int'l, Refurb | HH-0R03-XU-00 | FDA UDI | N/A | Unknown |
| Epoc Reader, Veterinary, Heska, Refurb | HR-1R03-US-00 | FDA UDI | N/A | Unknown |
| Epoc Host, Refurbished | HH-0R03-00-00 | FDA UDI | Class II | Active |
| Epoc Host, Rx | HH-0005-00-00 | FDA UDI | Class II | Active |
| Epoc Host, Rx, Japanese, Refurb | HH-0R10-JP-JP | FDA UDI | N/A | Unknown |
| Epoc Bgem Bun Test Card | 10736515 | FDA UDI | N/A | Unknown |
| Host 2, Epoc, Japanese, Veterinary | HH-1010-JP-JP | FDA UDI | N/A | Unknown |
| Epoc Host Mobile Computer, Int'l | HH-0003-XU-00 | FDA UDI | N/A | Unknown |
| Epoc Host 2, Veterinary, China | HH-1010-CN-ZH | FDA UDI | N/A | Unknown |
| Epoc Host, Rx, Vet, Int'l, Refurb | HH-0R07-00-00 | FDA UDI | N/A | Unknown |
| Epoc Host, Rx, Ca, Refurbished | HH-0R05-CA-00 | FDA UDI | Class II | Active |
| Epoc Host, Rx, Int'l | HH-0005-XU-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Simplified Chinese, Refurb | HH-1R09-CN-ZH | FDA UDI | N/A | Unknown |
| epoc Host2 | 11413524 | FDA UDI | Class II | Active |
| Epoc Host, Ca, Refurbished | HH-0R03-CA-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Veterinary | HH-1010-00-00 | FDA UDI | N/A | Unknown |
| Epoc Host, Rx, Japanese | HH-0010-JP-JP | FDA UDI | Class II | Active |
| Epoc Host Mobile Computer | HH-0003-00-00 | FDA UDI | Class II | Active |
| Epoc Host, Rx, Int'l, Refurb | HH-0R05-XU-00 | FDA UDI | Class II | Active |
| Epoc Reader, Refurbished, Rohs Compliant | HR-1R04-00-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Japanese, Refurbished | HH-1R09-JP-JP | FDA UDI | Class II | Active |
| Host 2, Epoc, Japanese | HH-1009-JP-JP | FDA UDI | Class II | Active |
| Epoc Reader, Refurbished, Rohs, Vet | HR-1R05-00-00 | FDA UDI | N/A | Unknown |
| Host 2, Epoc | HH-1009-00-00 | FDA UDI | Class II | Active |
| Epoc Bgem Crea Test Card, Veterinary | CT-1007-00-00 | FDA UDI | N/A | Unknown |
| Epoc Reader, Veterinary, Ce | HR-1003-00-00 | FDA UDI | N/A | Unknown |
| Epoc Host, Rx, Ca | HH-0005-CA-00 | FDA UDI | Class II | Active |
| Epoc Host, Int'l, Japanese, Refurbished | HH-0R03-XU-JP | FDA UDI | N/A | Unknown |
| Epoc Host, Rx, Vet, Japanese, Refurb | HH-0R11-JP-JP | FDA UDI | N/A | Unknown |
| Epoc Host 2, Veterinary, Heska | HH-1010-US-00 | FDA UDI | N/A | Unknown |
| Host 2, Epoc, Japanese, Vet, Refurbished | HH-1R10-JP-JP | FDA UDI | N/A | Unknown |
| Epoc Host, Veterinary, Ce, Refurbished | HH-0R04-00-00 | FDA UDI | N/A | Unknown |
| Epoc Reader, Refurbished | HR-1R02-00-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Veterinary, Refurbished | HH-1R10-00-00 | FDA UDI | N/A | Unknown |
| Epoc Bgem Crea Test Card, Vet, Heska | CT-1007-US-00 | FDA UDI | N/A | Unknown |
| Epoc Host 2, Veterinary, China, Refurbished | HH-1R10-CN-ZH | FDA UDI | N/A | Unknown |
| Edm Lite Kit | SD-0004-00-00 | FDA UDI | N/A | Unknown |
| Epoc Host 2, Ca, Refurbished | HH-1R09-CA-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Refurbished | HH-1R09-00-00 | FDA UDI | Class II | Active |
| Epoc Reader | HR-1002-00-00 | FDA UDI | Class II | Active |
| Epoc Reader, Veterinary, Ce, Refurbished | HR-1R03-00-00 | FDA UDI | N/A | Unknown |
| Epoc Bgem Crea Test Card | CT-1006-00-00 | FDA UDI | Class II | Active |
| Epoc Host, Rx, Refurb | HH-0R05-00-00 | FDA UDI | Class II | Active |
| Epoc Host 2, Ca | HH-1009-CA-00 | FDA UDI | Class II | Active |
| Host 2, Epoc, Simplified Chinese | HH-1009-CN-ZH | FDA UDI | Class II | Active |
| Epoc Host 2, Veterinary, Heska, Refurb | HH-1R10-US-00 | FDA UDI | N/A | Unknown |
| Epoc Bgem Test Card | CT-1004-00-00 | FDA UDI | Class II | Active |
| Epoc Bgem Lac Test Card, Vet | CT-1005-00-00 | FDA UDI | N/A | Unknown |
| Tube, Capillary, Veterinary, (bundle 50) | AT-0007-00-00 | FDA UDI | N/A | Unknown |
| epoc NXS Host | 11413475 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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 |
|---|---|---|---|---|
| Mar 13, 2013 | Z-1971-2013 | — | terminated | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range. |
| Jun 28, 2011 | Z-2034-2012 | — | terminated | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results. |
| Oct 16, 2008 | Z-0952-2009 | — | terminated | elevated range of potassium levels |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Epocal, Inc. Ottawa Ontario · CA FEI 3004959793