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Sign in to claim this brandErbe Medical, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 405 W Geneva Dr, Tempe, AZ, 85282
- Website
- erbe-usa.com
- —
- —
- [email protected]
- Phone
- 1-770-955-4400
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3020712480
- DUNS Number
- 117862528
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ERBEFLO AeroRinse® | 20325-233 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-202 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-203 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-240 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-214 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-218 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-208 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-205 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-209 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-239 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-212 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-223 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-248 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-243 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-206 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-201 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-219 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-231 | FDA UDI | Class II | Active |
| ERBEFLO CleverCap® | 20325-207 | FDA UDI | Class II | Active |
| Erbeflo® | 20325-225 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-213 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-232 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-237 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-224 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-215 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-222 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-235 | FDA UDI | Class II | Active |
| Erbeflo® 2 | 20325-211 | FDA UDI | Class II | Active |
| ERBEFLO AeroRinse® | 20325-236 | FDA UDI | Class II | Active |
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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 31, 2026 | Z-2063-2026 | — | open, classified | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. |
| Mar 31, 2026 | Z-2062-2026 | — | open, classified | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. |
| Mar 31, 2026 | Z-2064-2026 | — | open, classified | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. |