Identity
- Trade Name
- Healeon Duet EUDAMED
- Device Name
- Healeon Duet EUDAMED
- Model / Reference
- HM-DUET EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511085 EUDAMED
- Basic UDI-DI
- B-00850034511085 EUDAMED
- EMDN Code
- B06 CELLULAR OR BIOLOGICAL MANIPULATION DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Healeon Duet by Bimini Health Tech — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850034511085 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bimini Health Tech
- EUDAMED SRN
- US-MF-000008649
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9f171af4-be07-4f3e-86e2-376a2eed67de 61 fields · synced Jul 10, 2026