Identity
- Device Name
- HexaFlow Irrigation Pump EUDAMED
- Model / Reference
- AFR-00005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00763000871871 EUDAMED
- Basic UDI-DI
- 0763000B00026258A EUDAMED
- EMDN Code
- A03010299 IRRIGATION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HexaFlow Irrigation Pump by Medtronic, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763000B00026258A | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
- EUDAMED SRN
- US-MF-000019977
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (1)
- EUDAMED 6d09a445-7fc8-40eb-ba13-5f8c82f8e5be 61 fields · synced Jul 15, 2026